Home / 510(k) Clearances / K182218

510(k) K182218

FerriSmart Analysis System by Resonance Health Analysis Services Pty, Ltd. — Product Code PCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2018
Date Received
August 15, 2018
Clearance Type
Traditional
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)
  • K122035 — HEPAFAT SCAN (December 13, 2013)
  • DEN130012 — FERRISCAN R2-MRI ANALYSIS SYSTEM (January 23, 2013)
  • K111222 — MRI-Q SYSTEM (July 28, 2011)

Other clearances for product code PCS

  • K213776 — LiverSmart (December 29, 2021)
  • DEN130012 — FERRISCAN R2-MRI ANALYSIS SYSTEM (January 23, 2013)