Devices · Resonance Health Analysis Services Pty Ltd

LiverSmart

Resonance Health Analysis Services Pty Ltd is listed for LiverSmart (K213776). The FDA list gives December 29, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PCS as “Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213776

Official FDA database record

Date of final decision

December 29, 2021

Company on the FDA list

Resonance Health Analysis Services Pty Ltd

Lead panel

Radiology

Primary product code

PCS

openFDA device name for the code

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Device class

2

Regulation number

892.1001

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary