510(k) DEN130012
DEN130012 is an FDA 510(k) premarket notification submitted by Resonance Health Analysis Services Pty, Ltd. for the device "FERRISCAN R2-MRI ANALYSIS SYSTEM". The FDA issued a decision of De Novo Granted on January 23, 2013. The device falls under product code PCS (Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox), a Class II device regulated under 21 CFR 892.1001. Resonance Health Analysis Services Pty, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 23, 2013
- Date Received
- January 2, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- Device Class
- Class II
- Regulation Number
- 892.1001
- Review Panel
- RA
- Submission Type
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.