9 devices · 2 companies · 2020 to 2026

Qure.Ai Technologies: AI-enabled devices on FDA's list

9 devices from Qure.Ai Technologies, 2020 to 2026, from 2 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 9 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Qure.Ai Technologies

Every device, newest decision first

Qure.Ai Technologies · 9 devices
DecisionDevicePanelProduct codeFDA
qXR-DetectK251934 · 510(k)RadiologyMYNdatabase entry
qER-CTAK251610 · 510(k)RadiologyQASdatabase entry
qCT LN QuantK240740 · 510(k)RadiologyQIHdatabase entry
qXR-LNK231805 · 510(k)RadiologyMYNdatabase entry
qXR-CTRK231149 · 510(k)RadiologyQIHdatabase entry
qXR-PTX-PEK230899 · 510(k)RadiologyQFMdatabase entry
qXR-BTK212690 · 510(k)RadiologyQIHdatabase entry
qER-QuantK211222 · 510(k)RadiologyQIHdatabase entry
qERK200921 · 510(k)RadiologyQASdatabase 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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