DEN130012 is an FDA 510(k) submission for the FERRISCAN R2-MRI ANALYSIS SYSTEM. This device is classified as a Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox (Class II - Special Controls, product code PCS).
Submitted by Resonance Health Analysis Services Pty, Ltd. (Irvine, US). The FDA issued a Not Cleared (DENG) decision on January 23, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1001. Intended For Diagnostic Use To Present Images That Reflect The Magnetic Resonance Spectra For The Determination Of Iron In The Liver For Any Indication Where An Assessment Of Liver Iron Concentration Is Needed. For Non-transfusion-dependent Thalassemia (ntdt) Patients, Is Intended As An Aid In The Assessment Of Ntdt Patients For Whom Deferasirox Therapy Is Being Considered And For Monitoring Of Ntdt Patients Receiving Deferasirox Therapy..
| 510(k) Number | DEN130012 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 02, 2013 |
| Decision Date | January 23, 2013 |
| Days to Decision | 21 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | PCS - Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1001 |
| Definition | Intended For Diagnostic Use To Present Images That Reflect The Magnetic Resonance Spectra For The Determination Of Iron In The Liver For Any Indication Where An Assessment Of Liver Iron Concentration Is Needed. For Non-transfusion-dependent Thalassemia (ntdt) Patients, Is Intended As An Aid In The Assessment Of Ntdt Patients For Whom Deferasirox Therapy Is Being Considered And For Monitoring Of Ntdt Patients Receiving Deferasirox Therapy. |