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PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K213776resonance health analysis services ptyLiverSmartDecember 29, 2021
K182218resonance health analysis services ptyFerriSmart Analysis SystemNovember 30, 2018
DEN130012resonance health analysis services ptyFERRISCAN R2-MRI ANALYSIS SYSTEMJanuary 23, 2013