FDA-cleared K210426
HS40 Diagnostic Ultrasound System
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-05-13
Vendor
Samsung Medison CO., LTD.
17 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K211945
V8 Diagnostic Ultrasound System
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-08
FDA-cleared K211824
HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-09
FDA-cleared K220043
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., LTD
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-04-05
FDA-cleared K220975
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-29
FDA-cleared K221599
HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-08-22
FDA-cleared K223387
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-02-13
FDA-cleared K230084
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-04-21
FDA-cleared K231772
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-03
FDA-cleared K233112
HM70 EVO Diagnostic Ultrasound System
Samsung Medison CO., LTD.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-12-21
FDA-cleared K240516
RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-06-12
FDA-cleared K240631
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-06-21
FDA-cleared K241971
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-11
FDA-cleared K242444
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-27
FDA-cleared K242511
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-12-10
FDA-cleared K243702
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-12
FDA-cleared K250999
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-18