510(k) K182218
K182218 is an FDA 510(k) premarket notification submitted by Resonance Health Analysis Services Pty, Ltd. for the device "FerriSmart Analysis System". The FDA issued a decision of Substantially Equivalent on November 30, 2018. 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
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2018
- Date Received
- August 15, 2018
- Clearance Type
- Traditional
- 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.