3 devices · 1 company · 2017 to 2021

AmCad BioMed Corporation: AI-enabled devices on FDA's list

3 devices from AmCad BioMed Corporation, 2017 to 2021, 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 (3 of 3 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from AmCad BioMed Corporation

Every device, newest decision first

AmCad BioMed Corporation · 3 devices
DecisionDevicePanelProduct codeFDA
AmCAD-UTK203555 · 510(k)RadiologyQIHdatabase entry
AmCAD-UOK180867 · 510(k)RadiologyLLZdatabase entry
AmCAD-UVK170069 · 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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