PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox Class II
FDA product code PCS covers "Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox", a Class II medical device regulated under 21 CFR 892.1001. Submissions are reviewed by the Radiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCS
- Device Class
- Class II
- Regulation Number
- 892.1001
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213776 | resonance health analysis services pty | LiverSmart | December 29, 2021 |
| K182218 | resonance health analysis services pty | FerriSmart Analysis System | November 30, 2018 |
| DEN130012 | resonance health analysis services pty | FERRISCAN R2-MRI ANALYSIS SYSTEM | January 23, 2013 |