3 devices · 1 company · 2020 to 2022

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

3 devices from GE Medical Systems Ultrasound and, 2020 to 2022, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

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GE Medical Systems Ultrasound and · 3 devices
DecisionDevicePanelProduct codeFDA
Vivid E80, Vivid E90, Vivid E95K220882 · 510(k)RadiologyIYNdatabase entry
Vivid iqK200708 · 510(k)RadiologyIYNdatabase entry
Vivid E80/ Vivid E90/ Vivid E95K200743 · 510(k)RadiologyIYNdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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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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