Fabricant

Samsung Medison Co., Ltd.

18 dispositifs d'IA médicale autorisés par la FDA, de 2021 à 2026.

Radiologie (18)
Radiologie 510(k) 05/01/2026 · K252018
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 18/07/2025 · 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
Échographe Doppler pulsé
Radiologie 510(k) 12/02/2025 · 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
Échographe Doppler pulsé
Radiologie 510(k) 10/12/2024 · 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
Échographe Doppler pulsé
Radiologie 510(k) 27/11/2024 · K242444
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 11/10/2024 · K241971
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 21/06/2024 · K240631
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 12/06/2024 · K240516
RS85 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 21/12/2023 · K233112
HM70 EVO Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 03/10/2023 · K231772
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 21/04/2023 · K230084
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 13/02/2023 · K223387
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 22/08/2022 · K221599
HS40 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 29/06/2022 · K220975
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 05/04/2022 · K220043
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 09/09/2021 · K211824
HERA W9, HERA W10 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 08/09/2021 · K211945
V8 Diagnostic Ultrasound System
Échographe Doppler pulsé
Radiologie 510(k) 13/05/2021 · K210426
HS40 Diagnostic Ultrasound System
Échographe Doppler pulsé

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