Cleared Special

K213776 - LiverSmart (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213776 · Resonance Health Analysis Services Pty, Ltd. · Radiology device
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Dec 2021
Decision
27d
Days
Class 2
Risk

K213776 is an FDA 510(k) clearance for the LiverSmart. Classified as Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox (product code PCS), Class II - Special Controls.

Submitted by Resonance Health Analysis Services Pty, Ltd. (Perth, AU). The FDA issued a Cleared decision on December 29, 2021 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1001 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Resonance Health Analysis Services Pty, Ltd. devices

Submission Details

510(k) Number K213776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2021
Decision Date December 29, 2021
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PCS Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1001
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.