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Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PCS

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Class 2

21 CFR 892.1001

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Radiology

Device Characteristics

No

No

No

Not Eligible

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.