PCSClass II

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

21 CFR 892.1001 / Radiology

PCS is the FDA product code for Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox, a class II device type, regulated under 21 CFR 892.1001. FDA's definition for this code 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 non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT...". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2021-12-29, and no recalls.

Classification record

Product code: PCS
Device name: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
FDA 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.
Regulation: 21 CFR 892.1001
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code PCS

By decision year

3 clearances under product code PCS with a decision year between 2013 and 2021, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PCS by decision year
Year	Clearances
2013	1
2018	1
2021	1

Applicants with the most clearances

Product code PCS

Applicants holding the most 510(k) clearances under product code PCS
Applicant	Clearances
Resonance Health Analysis Services Pty Ltd	3

Companies listing this code with FDA

Companies whose registered establishments list this code

Resonance Health Analysis Services Pty Ltd

Recent clearances

Product code PCS

Recent recalls

Product code PCS

FDA records show no recalls under product code PCS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)