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510(k) DEN130012

FERRISCAN R2-MRI ANALYSIS SYSTEM by Resonance Health Analysis Services Pty, Ltd. — Product Code PCS

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
January 23, 2013
Date Received
January 2, 2013
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Device Class
Class II
Regulation Number
892.1001
Review Panel
RA
Submission Type

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.

Other clearances by Resonance Health Analysis Services Pty, Ltd.

  • K231459 — HepaFatSmart (V2.0.0) (June 20, 2023)
  • K213776 — LiverSmart (December 29, 2021)
  • K201039 — HepaFat-AI (December 7, 2020)
  • K182218 — FerriSmart Analysis System (November 30, 2018)
  • K122035 — HEPAFAT SCAN (December 13, 2013)
  • K111222 — MRI-Q SYSTEM (July 28, 2011)

Other clearances for product code PCS

  • K213776 — LiverSmart (December 29, 2021)
  • K182218 — FerriSmart Analysis System (November 30, 2018)