510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130012Unknown

Ferriscan R2-MRI Analysis System

Resonance Health Analysis Services Pty Ltd, Irvine CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130012 is the FDA 510(k) clearance record for FERRISCAN R2-MRI ANALYSIS SYSTEM, a class II device, cleared for Resonance Health Analysis Services Pty, Ltd. on under FDA product code PCS (Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox). FDA's definition for product code PCS reads: "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...". FDA records list 7 510(k) clearances for Resonance Health Analysis Services Pty, Ltd., from to . As of , FDA records show no recalls naming DEN130012.

Clearance record

Decision date
Received
(21 days to decision)
Product code
PCS Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Regulation
21 CFR 892.1001
Device class
Class II
Review panel
Radiology
Applicant
Resonance Health Analysis Services Pty, Ltd. 3722 Ave. Sausalito, Irvine CA
Third party review
No

Clearances, product code PCS

Trailing 12 months

FDA records hold no clearances under product code PCS in the trailing twelve months.

FDA records show no clearances under product code PCS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260