5 devices · 1 company · 2024 to 2025

Peek Health, S.A.: AI-enabled devices on FDA's list

5 devices from Peek Health, S.A., 2024 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Peek Health, S.A.

Every device, newest decision first

Peek Health, S.A. · 5 devices
DecisionDevicePanelProduct codeFDA
PeekMed webK252856 · 510(k)RadiologyQIHdatabase entry
PeekMed webK252452 · 510(k)RadiologyQIHdatabase entry
PeekMed webK251096 · 510(k)RadiologyQIHdatabase entry
PeekMed webK250042 · 510(k)RadiologyQIHdatabase entry
PeekMed webK240926 · 510(k)RadiologyLLZdatabase 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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