Cleared Traditional

VIRTUOST (K113725) - FDA 510(k) Clearance

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

K113725 · O.N. Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
269d
Days
Class 2
Risk

K113725 is an FDA 510(k) clearance for the VIRTUOST. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by O.N. Diagnostics (Berkeley, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 269 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - 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.

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Submission Details

510(k) Number K113725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date September 13, 2012
Days to Decision 269 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
162d slower than avg
Panel avg: 107d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
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.

Regulatory Peers - KGI Densitometer, Bone

All 40
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K113725.
GEHC DXA Bone Densitometers with enCORE version 18
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Aria
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SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · Hologic, Inc. · May 2013
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · Hologic, Inc. · Mar 2012
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · Hologic, Inc. · Mar 2011
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co. · Sep 2008