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18 devices · 3 companies · 2021 to 2026

Samsung Medison Co., Ltd.: AI-enabled devices on FDA's list

18 devices from Samsung Medison Co., Ltd., 2021 to 2026, from 3 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (18 of 18 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Every device, newest decision first

Samsung Medison Co., Ltd. · 18 devices
DecisionDevicePanelProduct codeFDA
HERA Z20 Diagnostic Ultrasound SystemK252018 · 510(k)RadiologyIYNdatabase entry
V8 Diagnostic Ultrasound SystemK250999 · 510(k)RadiologyIYNdatabase entry
V8 Diagnostic Ultrasound SystemK243702 · 510(k)RadiologyIYNdatabase entry
V5 Diagnostic Ultrasound System, H5 Diagnostic UK242511 · 510(k)RadiologyIYNdatabase entry
HERA W10 Diagnostic Ultrasound SystemK242444 · 510(k)RadiologyIYNdatabase entry
HERA Z20, R20, HERA Z30, R30 Diagnostic UltrasouK241971 · 510(k)RadiologyIYNdatabase entry
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic UlK240631 · 510(k)RadiologyIYNdatabase entry
RS85 Diagnostic Ultrasound SystemK240516 · 510(k)RadiologyIYNdatabase entry
HM70 EVO Diagnostic Ultrasound SystemK233112 · 510(k)RadiologyIYNdatabase entry
V8/H8 Diagnostic Ultrasound System, V7/H7 DiagnoK231772 · 510(k)RadiologyIYNdatabase entry
HERA W10 Diagnostic Ultrasound SystemK230084 · 510(k)RadiologyIYNdatabase entry
V8 Diagnostic Ultrasound System, V7 Diagnostic UK223387 · 510(k)RadiologyIYNdatabase entry
HS40 Diagnostic Ultrasound SystemK221599 · 510(k)RadiologyIYNdatabase entry
V8 Diagnostic Ultrasound System, V7 Diagnostic UK220975 · 510(k)RadiologyIYNdatabase entry
HERA W10 Diagnostic Ultrasound System, HERA W9 DK220043 · 510(k)RadiologyIYNdatabase entry
HERA W9, HERA W10 Diagnostic Ultrasound SystemK211824 · 510(k)RadiologyIYNdatabase entry
V8 Diagnostic Ultrasound SystemK211945 · 510(k)RadiologyIYNdatabase entry
HS40 Diagnostic Ultrasound SystemK210426 · 510(k)RadiologyIYNdatabase entry

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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