FDA-cleared K163138
Clarius Mobile Health Corp.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3)
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2016-11-30
FDA-cleared K161959
ClearView Diagnostics Inc.
earView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.
- Modality
- Ultrasound
- Anatomy
- Breast
- Decision
- 2016-12-28
FDA-cleared K170069
AmCad BioMed Corporation
It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2017-04-26
FDA-cleared K170747
Siemens Medical Solutions, USA, Inc.
syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange...
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2017-06-09
FDA-cleared K172385
Clarius Mobile Health Corp.
DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS : Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) BM Color...
- Modality
- Ultrasound
- Anatomy
- Abdomen
- Decision
- 2017-09-14
FDA-cleared K172356
Verathon Incorporated
BladderScan PRIME PLUS system Transducer: N/A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously...
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2017-09-15
FDA-cleared K180599
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-05-02
FDA-cleared K173810
Ventripoint Diagnostics, Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-05-14
FDA-cleared K180799
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-05-14
FDA-cleared K173780
Bay Labs, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-06-14
FDA-cleared K181574
EchoNous, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-07-10
FDA-cleared K181685
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-10-25
FDA-cleared K180867
AmCad BioMed Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-12-28
FDA-cleared K192107
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2019-08-29
FDA-cleared K191171
Ultromics Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2019-11-13
FDA-cleared K191647
Philips Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2019-12-20
FDA-cleared K192388
Tissue Differentiation Intelligence, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-03-12
FDA-cleared K193518
EchoNous, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-03-26
FDA-cleared K200755
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-04-16
FDA-cleared K201012
Philips Ultrasound, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-05-01
FDA-cleared K200974
Philips Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-06-03
FDA-cleared K200980
Butterfly Network, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-06-11
FDA-cleared K200497
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-07-16
FDA-cleared K200743
GE Medical Systems Ultrasound and
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-07-23
FDA-cleared K200708
GE Medical Systems Ultrasound and
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-09
FDA-cleared K200851
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-09
FDA-cleared K200852
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-18
FDA-cleared K201992
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-18
FDA-cleared K202546
DiA Imaging Analysis Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-29
FDA-cleared K201555
Ultromics Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-12-18
FDA-cleared K203502
MEDO DX Pte. Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-04-23
FDA-cleared K210426
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-05-13
FDA-cleared K210791
eko.ai Pte. Ltd. d/b/a Us2.ai
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-07-27
FDA-cleared K212100
EchoNous, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-08-06
FDA-cleared K203555
AmCad BioMed Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-08
FDA-cleared K211597
Philips Medical Systems
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-08
FDA-cleared K211945
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-08
FDA-cleared K211824
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-09
FDA-cleared K210438
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-10
FDA-cleared K212704
Philips Medical Systems
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-24
FDA-cleared K211161
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-10-29
FDA-cleared K213436
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-11-15
FDA-cleared K212265
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-11-16
FDA-cleared K212466
DiA Imaging Analysis Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-12-09
FDA-cleared K213275
Ultromics Limited
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-12-20
FDA-cleared K213642
GE Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-13
FDA-cleared K210747
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-19
FDA-cleared K212012
Cycle Clarity
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-19
FDA-cleared K212333
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-24
FDA-cleared K213689
GE Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-02-17
FDA-cleared K212960
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-03-22
FDA-cleared K220043
Samsung Medison Co., LTD
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-04-05
FDA-cleared K220446
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-05-11
FDA-cleared K220358
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-06
FDA-cleared K220800
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-21
FDA-cleared K220848
GE Medical Systems
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-27
FDA-cleared K220851
GE Medical Systems
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-27
FDA-cleared K220975
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-29
FDA-cleared K220619
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-15
FDA-cleared K221147
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-18
FDA-cleared K221148
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-18
FDA-cleared K220956
Dyad Medical, Inc
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-20
FDA-cleared K220882
GE Medical Systems Ultrasound and
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-22
FDA-cleared K220940
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-22
FDA-cleared K221599
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-08-22
FDA-cleared K222970
DiA Imaging Analysis Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-02-01
FDA-cleared K223387
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-02-13
FDA-cleared K220068
Butterfly Network, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-03-31
FDA-cleared K223830
BK Medical Aps
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-04-11
FDA-cleared K223287
Sonic Incytes
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-04-20
FDA-cleared K230084
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-04-21
FDA-cleared K223771
Philips Ultrasound
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-05-04
FDA-cleared K231190
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-05-12
FDA-cleared K230346
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-06-20
FDA-cleared K230497
Exo Inc
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-06-22
FDA-cleared K230365
Sonio
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-07-25
FDA-cleared K231772
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-03
FDA-cleared K232704
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-05
FDA-cleared K231764
BK Medical Aps
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-23
FDA-cleared K232500
Philips Ultrasound
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-26
FDA-cleared K231965
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-30
FDA-cleared K232145
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-30
FDA-cleared K231966
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-07
FDA-cleared K231989
GE Medical Systems Ultrasound and Primary Care Diagnostic,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-07
FDA-cleared K232257
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-13
FDA-cleared K232501
Exo Inc
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-17
FDA-cleared K230179
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-29
FDA-cleared K233545
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-30
FDA-cleared K232381
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-12-07
FDA-cleared K233112
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-12-21
FDA-cleared K232808
Butterfly Network, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-01-04
FDA-cleared K233195
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-01-24
FDA-cleared K233788
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-02-13
FDA-cleared K231677
Edgecare Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-03-06
FDA-cleared K233692
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-03-07
FDA-cleared K233676
Eko.ai Pte. Ltd d/b/a Us2.ai
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-04-01
FDA-cleared K240850
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-04-24
FDA-cleared K232331
InVision Medical Technology Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-04-25
FDA-cleared K240406
Sonio
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-04-26
FDA-cleared K240769
DiA Imaging Analysis Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-05-24
FDA-cleared K240516
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-06-12
FDA-cleared K233955
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-06-14
FDA-cleared K240631
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-06-21
FDA-cleared K240704
Siemens Medical Solutions, USA, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-07-22
FDA-cleared K240953
Exo Imaging
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-08-05
FDA-cleared K233826
EchoNous, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-08-29
FDA-cleared K233977
Sonic Incytes
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-09-04
FDA-cleared K240094
Augmedit B.V.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-09-10
FDA-cleared K241380
Diagnoly
Image analysis/processing for Heart using Ultrasound.
- Modality
- Ultrasound
- Anatomy
- Heart
- Decision
- 2024-09-11
FDA-cleared K241582
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-09-12
FDA-cleared K240036
PIUR Imaging GmbH
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-09-20
FDA-cleared K242005
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-02
FDA-cleared K240553
DiA Imaging Analysis Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-04
FDA-cleared K241245
Echo IQ Ltd
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-04
FDA-cleared K240980
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-07
FDA-cleared K241029
Verdure Imaging
Image analysis/processing for Spine using Ultrasound.
- Modality
- Ultrasound
- Anatomy
- Spine
- Decision
- 2024-10-07
FDA-cleared K241430
iCardio.ai
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-10
FDA-cleared K241971
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-11
FDA-cleared K242342
BrightHeart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-14
FDA-cleared K242800
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-15
FDA-cleared K242523
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-19
FDA-cleared K242359
Exo Inc
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-20
FDA-cleared K242444
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-27
FDA-cleared K242511
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-12-10
FDA-cleared K242020
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-12-12
FDA-cleared K242168
GE Medical Systems Ultrasound and Primary care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-12-20
FDA-cleared K241949
Sonoscape Medical Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-01-17
FDA-cleared K241593
Gleamer SAS
Image analysis/processing for Bone using Ultrasound.
- Modality
- Ultrasound
- Anatomy
- Bone
- Decision
- 2025-02-05
FDA-cleared K243794
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-06
FDA-cleared K241659
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-10
FDA-cleared K243620
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-11
FDA-cleared K243628
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-11
FDA-cleared K243702
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-12
FDA-cleared K241620
Gleamer SAS
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-27
FDA-cleared K243235
DiA Imaging Analysis Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-03-03
FDA-cleared K243331
DiA Imaging Analysis Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-03-06
FDA-cleared K243862
DiA Imaging Analysis Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-03-17
FDA-cleared K250177
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-04-10
FDA-cleared K250328
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-04-30
FDA-cleared K250087
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-01
FDA-cleared K251071
BrightHeart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-02
FDA-cleared K250226
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-08
FDA-cleared K251110
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-09
FDA-cleared K241671
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-16
FDA-cleared K243793
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K242594
DeepEcho
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-23
FDA-cleared K243937
Rivanna Medical, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-23
FDA-cleared K250543
GE Medical Systems Ultrasound and Primary care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-29
FDA-cleared K243253
Esaote S.p.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-06-18
FDA-cleared K250886
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-06-18
FDA-cleared K250670
Mycardium AI Limited
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-06-30
FDA-cleared K251169
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-10
FDA-cleared K251342
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-16
FDA-cleared K250999
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-18
FDA-cleared K251455
Philips Ultrasound LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-24
FDA-cleared K251322
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-25
FDA-cleared K251481
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-08-20
FDA-cleared K251106
Fujifilm Sonosite Inc
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-08-29
FDA-cleared K251368
Diagnoly
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-09-12
FDA-cleared K252007
Deep Breathe, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-06
FDA-cleared K251651
Philips Ultrasound, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-09
FDA-cleared K251673
X9, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-17
FDA-cleared K251963
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-29
FDA-cleared K251985
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-29
FDA-cleared K252074
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-31
FDA-cleared K252328
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-11-24
FDA-cleared K253310
Esaote, S.P.A.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-11-25
FDA-cleared K252294
Brightheart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-08
FDA-cleared K252235
Ultrasight , Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-18
FDA-cleared K250959
Bioticsai, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared K252557
Philips Ultrasound, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22