3 devices · 1 company · 2023 to 2024

Siemens Medical Solutions U.S.A.: AI-enabled devices on FDA's list

3 devices from Siemens Medical Solutions U.S.A., 2023 to 2024, from 1 company across 3 product codes. 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.

Product codes from Siemens Medical Solutions U.S.A.

Every device, newest decision first

Siemens Medical Solutions U.S.A. · 3 devices
DecisionDevicePanelProduct codeFDA
AI-Rad Companion Organs RTK232899 · 510(k)RadiologyQKBdatabase entry
AI-Rad Companion Brain MRK232305 · 510(k)RadiologyQIHdatabase entry
AI-Rad CompanionK222360 · 510(k)RadiologyJAKdatabase 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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