2 devices · 1 company · 2018 to 2021
Product code PCS: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
2 devices under product code PCS, 2018 to 2021, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox. 21 CFR 892.1001, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| LiverSmartK213776 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | database entry | |
| FerriSmart Analysis SystemK182218 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | database entry |
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