3 devices · 1 company · 2023 to 2025

Axial Medical Printing Limited: AI-enabled devices on FDA's list

3 devices from Axial Medical Printing Limited, 2023 to 2025, 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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Axial Medical Printing Limited · 3 devices
DecisionDevicePanelProduct codeFDA
Axial3D InsightK250369 · 510(k)RadiologyQIHdatabase entry
Axial3D InsightK232841 · 510(k)RadiologyQIHdatabase entry
Axial3D InsightK222745 · 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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