3 devices · 2 companies · 2021 to 2024
MRIguidance B.V: AI-enabled devices on FDA's list
3 devices from MRIguidance B.V, 2021 to 2024, from 2 companies 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.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| BoneMRIK233030 · 510(k) | Radiology | QIH | database entry | |
| BoneMRI v1.6K230197 · 510(k) | Radiology | QIH | database entry | |
| BoneMRIK202404 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.