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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Postprocessing software for the measurement of liver iron concentration (LIC) from magnetic resonance imaging (MRI) data.
Technical Method Uses MRI data combined with an empirically-derived calibration curve to determine liver iron concentration (LIC).
Target Area liver
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodePCS
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1001
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible