DeviceClearance

Product code PCS— Radiology

FERRISCAN R2-MRI ANALYSIS SYSTEM

Classification name
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Device class
Class 2
Regulation
21 CFR 892.1001
Advisory panel
Radiology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PCS under 21 CFR 892.1001, via openFDA

Market context for product code PCS

FDA has cleared 3 devices under product code PCS between 2013 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCS

Recent clearances under product code PCS

Data sourced from openFDA. This site is unofficial and independent of the FDA.