2 devices · 2 companies · 2023 to 2025

Feops NV: AI-enabled devices on FDA's list

2 devices from Feops NV, 2023 to 2025, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Feops NV

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Every device, newest decision first

Feops NV · 2 devices
DecisionDevicePanelProduct codeFDA
FEops HEARTguide Simulation ApplicationK250635 · 510(k)CardiovascularQQIdatabase entry
FEops HEARTguideTM, FEops HEARTguideTM ALPACAK223855 · 510(k)RadiologyQIHdatabase 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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