Not Cleared Direct

DEN130012 - FERRISCAN R2-MRI ANALYSIS SYSTEM (FDA 510(k) Clearance)

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

DEN130012 · Resonance Health Analysis Services Pty, Ltd. · Radiology device
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Jan 2013
Decision
21d
Days
Class 2
Risk

DEN130012 is an FDA 510(k) submission (not cleared) for the FERRISCAN R2-MRI 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. (Irvine, US). The FDA issued a Not Cleared (DENG) decision on January 23, 2013 after a review of 21 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Radiology review framework.

View all Resonance Health Analysis Services Pty, Ltd. devices

Submission Details

510(k) Number DEN130012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 02, 2013
Decision Date January 23, 2013
Days to Decision 21 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics

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.