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 Thalassem
| Device Type ID | 5420 |
| Device Name | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Physical State | Postprocessing Software For The Measurement Of Liver Iron Concentration (LIC) From Magnetic Resonance Imaging (MRI) Data. |
| Technical Method | Uses MRI Data Combined With An Empirically-derived Calibration Curve To Determine Liver Iron Concentration (LIC). |
| Target Area | Liver |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1001 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5420 |
| Device | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Product Code | PCS |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.1001 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |