The following data is part of a De Novo classification by Resonance Health Analysis Services Pty Ltd with the FDA for Ferriscan R2-mri Analysis System.
| DeNovo ID | DEN130012 |
| Device Name: | FERRISCAN R2-MRI ANALYSIS SYSTEM |
| Classification | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Applicant | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 Ave. Sausalito Irvine, CA 92606 |
| Contact | Greg Holland |
| Product Code | PCS |
| CFR Regulation Number | 892.1001 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K124065 |
| Review Advisory Board | Radiology |
| Classification Advisory | Radiology |
| Type | Direct |
| Date Received | 2013-01-02 |
| Decision Date | 2013-01-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |