3 devices · 2 companies · 2017 to 2024

CorTechs Labs, Inc.: AI-enabled devices on FDA's list

3 devices from CorTechs Labs, Inc., 2017 to 2024, 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 (3 of 3 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from CorTechs Labs, Inc.

Every device, newest decision first

CorTechs Labs, Inc. · 3 devices
DecisionDevicePanelProduct codeFDA
NeuroQuantK241098 · 510(k)RadiologyQIHdatabase entry
OnQ NeuroK210831 · 510(k)RadiologyQIHdatabase entry
NeuroQuantK170981 · 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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