Cleared Traditional

K182218 - FerriSmart Analysis System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182218 · Resonance Health Analysis Services Pty, Ltd. · Radiology device
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Nov 2018
Decision
107d
Days
Class 2
Risk

K182218 is an FDA 510(k) clearance for the FerriSmart Analysis System. 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 November 30, 2018 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1001 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Resonance Health Analysis Services Pty, Ltd. devices

Submission Details

510(k) Number K182218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date November 30, 2018
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.