2 devices · 1 company · 2024 to 2026

Exo Imaging: AI-enabled devices on FDA's list

2 devices from Exo Imaging, 2024 to 2026, 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 (1 of 2 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

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Exo Imaging · 2 devices
DecisionDevicePanelProduct codeFDA
AI Platform 2.2K260217 · 510(k)RadiologyQIHdatabase entry
AI Platform 2.0K240953 · 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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