4 devices · 1 company · 2018 to 2023
Resonance Health Analysis Services Pty Ltd: AI-enabled devices on FDA's list
4 devices from Resonance Health Analysis Services Pty Ltd, 2018 to 2023, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Resonance Health Analysis Services Pty Ltd
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| HepaFatSmartK231459 · 510(k) | Radiology | LNH | database entry | |
| LiverSmartK213776 · 510(k) | Radiology | PCS | database entry | |
| HepaFat-AIK201039 · 510(k) | Radiology | LNH | database entry | |
| FerriSmart Analysis SystemK182218 · 510(k) | Radiology | PCS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.