Cleared Traditional

K961787 - BODY COMPOSITION SOFTWARE OPTION FOR QD...

K961787 is an FDA 510(k) clearance for BODY COMPOSITION SOFTWARE OPTION FOR QD..., manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K961787 · Hologic, Inc. · Radiology device
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Jun 1997
Decision
400d
Days
Class 2
Risk

K961787 is an FDA 510(k) clearance for the BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Rockville, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K961787

510(k) Number K961787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1996
Decision Date June 13, 1997
Days to Decision 400 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
293d slower than avg
Panel avg: 107d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K961787.
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775 · Hologic, Inc. · Oct 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992677 · Hologic, Inc. · Sep 1999
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K983028 · Hologic, Inc. · Nov 1998
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363 · Hologic, Inc. · Nov 1996
BONE MINERAL DENSITOMETER
K941362 · Hologic, Inc. · Aug 1995
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505 · Hologic, Inc. · Jan 1995