FDA-authorized DEN180005
OsteoDetect
Imagen Technologies, Inc.
Computer-aided detection/diagnosis
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-05-24
Use case
Nuclear medicine radiology AI tools
A buyer-oriented shortlist for nuclear medicine. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K182218
FerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-11-30
FDA-cleared K182336
SubtlePET
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-11-30
FDA-cleared K193178
Biograph Horizon
Siemens Medical Solution USA, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-02-12
FDA-cleared K193248
Biograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, Inc
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-02-14
FDA-cleared K200760
Rapid ASPECTS
iSchemaView Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-06-26
FDA-cleared K193417
FractureDetect (FX)
Imagen Technologies, Inc.
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Bone
- Decision
- 2020-07-30
FDA-cleared K193210
HYPER DLR
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-08-04
FDA-cleared K203314
Cartesion Prime (PCD-1000A/3) V10.8
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-04-23
FDA-cleared K210001
HYPER AiR
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-04-30
FDA-cleared K211764
Vereos PET/CT
Philips Medical Systems Nederland B.V.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-08-06
FDA-cleared K212230
TruSPECT Radiological Image Processing Station
Spectrum Dynamics Medical Ltd
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-08-16
FDA-cleared K211846
Discovery MI Gen2
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-08-20
FDA-cleared K211964
SubtlePET
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-09-28
FDA-cleared K213776
LiverSmart
Resonance Health Analysis Services Pty Ltd
Image analysis/processing for Liver using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Liver
- Decision
- 2021-12-29
FDA-cleared K212365
BoneView
Gleamer
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Bone
- Decision
- 2022-03-01
FDA-cleared K220164
Rayvolve
AZmed SAS
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2022-06-02
FDA-cleared K221564
Brainomix 360 e-ASPECTS
Brainomix Limited
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-02-23
FDA-cleared K222176
BoneView
Gleamer
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Bone
- Decision
- 2023-03-02
FDA-cleared K223325
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-03-10
FDA-cleared K223212
Precision DL
GE Healthcare
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-04-27
FDA-cleared K223491
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLC
Image analysis/processing for Chest/Lung using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Chest/Lung
- Decision
- 2023-05-25
FDA-cleared K231833
Biograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-07-13
FDA-cleared K231572
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-07-26
FDA-cleared K231748
Cartesion Prime (PCD-1000A/3) V10.15
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-09-12
FDA-cleared K232712
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-10-03
FDA-cleared K233677
Biograph VK10
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-01-12
FDA-cleared K232156
Rapid ASPECTS (v3)
iSchemaView, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-01-19
FDA-cleared K233342
CINA-ASPECTS
Avicenna.AI
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-03-15
FDA-cleared K234154
uPMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-05-24
FDA-cleared K240845
Rayvolve
AZmed SAS
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-07-17
FDA-cleared K241665
Omni Legend
GE Medical Systems Israel, Functional Imaging
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-08-08
FDA-cleared K241596
uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-08-15
FDA-cleared K241585
uMI Panorama
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K240712
icobrain aria
icometrix NV
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-11-07
FDA-cleared K243538
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-12-12
FDA-cleared K242171
TechCare Trauma
Milvue
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-01-17
FDA-cleared K243294
Brainomix 360 e-ASPECTS
Brainomix Limited
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-02-14
FDA-cleared K243614
Sonio Suspect
Sonio
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-02-21
FDA-cleared K251153
Aurora
GE Medical Systems Israel
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-06-12
FDA-cleared K250221
StrokeSENS ASPECTS Software Application
Circle Cardiovascular Imaging Inc.
Image analysis/processing for Brain using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Brain
- Decision
- 2025-07-01
FDA-cleared K251839
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-07-17
FDA-cleared K251370
Cartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-12-01
FDA-cleared K253532
TruSPECT Processing Station
Spectrum Dynamics Medical, Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-12-30