Cleared Traditional

K963363 - HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

K963363 is an FDA 510(k) clearance for HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS, 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 87-day FDA review.

K963363 · Hologic, Inc. · Radiology device
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Nov 1996
Decision
87d
Days
Class 2
Risk

K963363 is an FDA 510(k) clearance for the HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on November 22, 1996 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K963363

510(k) Number K963363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date November 22, 1996
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 64
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K963363.
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · Hologic, Inc. · Jun 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · Lunar Corp. · Apr 1997
PIXI BONE DENSITOMETER
K970224 · Lunar Corp. · Apr 1997
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263 · Lunar Corp. · Nov 1996
EXPERT SPINE MORPHOTIETRY REFERENCE
K961007 · Lunar Corp. · Jul 1996
LUNAR REPORT GENERATOR
K961944 · Lunar Corp. · Jul 1996