PCS

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Device class

Class II (moderate risk)

Regulation

21 CFR 892.1001

Medical specialty

Radiology

FDA 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.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free