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Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA product code PCS · 2 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1001
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-11-30 – 2021-12-29

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.

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