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31 devices · 5 companies · 2018 to 2026

GE Medical Systems Ultrasound and Primary Care Diagnostics: AI-enabled devices on FDA's list

31 devices from GE Medical Systems Ultrasound and Primary Care Diagnostics, 2018 to 2026, from 5 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (30 of 31 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from GE Medical Systems Ultrasound and Primary Care Diagnostics

Every device, newest decision first

GE Medical Systems Ultrasound and Primary Care Diagnostics · 31 devices
DecisionDevicePanelProduct codeFDA
LOGIQ VitaK260673 · 510(k)RadiologyIYNdatabase entry
LOGIQ TotusK253370 · 510(k)RadiologyIYNdatabase entry
LOGIQ FortisK253366 · 510(k)RadiologyIYNdatabase entry
Voluson Expert 18K252328 · 510(k)RadiologyIYNdatabase entry
LOGIQ E10K251985 · 510(k)RadiologyIYNdatabase entry
LOGIQ E10sK251963 · 510(k)RadiologyIYNdatabase entry
VenueK251322 · 510(k)RadiologyIYNdatabase entry
EchoPAC Software Only / EchoPAC Plug-inK251342 · 510(k)RadiologyQIHdatabase entry
Vivid PioneerK251169 · 510(k)RadiologyIYNdatabase entry
Voluson Performance 16K250543 · 510(k)RadiologyIYNdatabase entry
Vscan AirK250087 · 510(k)RadiologyIYNdatabase entry
Vivid T9/Vivid T8K243628 · 510(k)RadiologyIYNdatabase entry
Vivid iqK243620 · 510(k)RadiologyIYNdatabase entry
Voluson Expert 18K242168 · 510(k)RadiologyIYNdatabase entry
Versana PremierK242005 · 510(k)RadiologyIYNdatabase entry
Voluson Signature 20, Voluson Signature 18K233692 · 510(k)RadiologyIYNdatabase entry
LOGIQ TotusK232381 · 510(k)RadiologyIYNdatabase entry
LOGIQ E10K231966 · 510(k)RadiologyIYNdatabase entry
Voluson Expert 22, Voluson Expert 20, Voluson ExK231965 · 510(k)RadiologyIYNdatabase entry
EchoPAC Software Only, EchoPAC Plug-inK220940 · 510(k)RadiologyQIHdatabase entry
Vivid T8, Vivid T9K221147 · 510(k)RadiologyIYNdatabase entry
Vivid S60N, Vivid S70NK220619 · 510(k)RadiologyIYNdatabase entry
Venue GoK220800 · 510(k)RadiologyIYNdatabase entry
Voluson Expert 22, Voluson Expert 20, Voluson ExK220358 · 510(k)RadiologyIYNdatabase entry
Versana BalanceK220446 · 510(k)RadiologyIYNdatabase entry
Versana PremierK210438 · 510(k)RadiologyIYNdatabase entry
EchoPAC Software Only, EchoPAC Plug-InK200852 · 510(k)RadiologyLLZdatabase entry
Vivid T8, Vivid T9K200851 · 510(k)RadiologyIYNdatabase entry
Vivid S60N, Vivid S70NK200497 · 510(k)RadiologyIYNdatabase entry
Vivid E80, Vivid E90, Vivid E95K181685 · 510(k)RadiologyIYNdatabase entry
VenueK180599 · 510(k)RadiologyIYNdatabase entry

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