Cleared Traditional

K103265 - NHANES WHOLE BODY DXA REFERENCE DATABASE

K103265 is the FDA 510(k) clearance for NHANES WHOLE BODY DXA REFERENCE DATABASE by Hologic, Inc.. It is a Class 2 Radiology device (product code KGI) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K103265 · Hologic, Inc. · Radiology device
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Mar 2011
Decision
132d
Days
Class 2
Risk

K103265 is an FDA 510(k) clearance for the NHANES WHOLE BODY DXA REFERENCE DATABASE. 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 16, 2011 after a review of 132 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 K103265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2010
Decision Date March 16, 2011
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
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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