Cleared Traditional

K201039 - HepaFat-AI

K201039 is an FDA 510(k) clearance for HepaFat-AI, manufactured by Resonance Health Analysis Services Pty, Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K201039 · Resonance Health Analysis Services Pty, Ltd. · Radiology device
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Dec 2020
Decision
231d
Days
Class 2
Risk

K201039 is an FDA 510(k) clearance for the HepaFat-AI. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Resonance Health Analysis Services Pty, Ltd. (Perth, AU). The FDA issued a Cleared decision on December 7, 2020 after a review of 231 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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

FDA 510(k) Submission Details - K201039

510(k) Number K201039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date December 07, 2020
Days to Decision 231 days
Submission Type Traditional
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
124d slower than avg
Panel avg: 107d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.

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All 840
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