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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device liver iron concentration imaging companion diagnostic for deferasirox
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.
Product CodePCS
Regulation Number 892.1001
Device Class 2


Premarket Reviews
ManufacturerDecision
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

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