Cleared Traditional

K113356 - HOLOGIC VISCERAL FAT SOFTWARE

K113356 is the FDA 510(k) clearance for HOLOGIC VISCERAL FAT SOFTWARE by Hologic, Inc.. It is a Class 2 Radiology device (product code KGI) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K113356 · Hologic, Inc. · Radiology device
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Mar 2012
Decision
113d
Days
Class 2
Risk

K113356 is an FDA 510(k) clearance for the HOLOGIC VISCERAL FAT SOFTWARE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on March 6, 2012 after a review of 113 days - within the typical 510(k) review window.

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.

View all Hologic, Inc. devices

Submission Details

510(k) Number K113356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date March 06, 2012
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
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 44
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