Cleared Traditional

K992775 - OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

K992775 is an FDA 510(k) clearance for OPTION FOR THE QDR BONE DENSITOMETER, 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 44-day FDA review.

K992775 · Hologic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
44d
Days
Class 2
Risk

K992775 is an FDA 510(k) clearance for the OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR40.... Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on October 1, 1999 after a review of 44 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 - K992775

510(k) Number K992775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1999
Decision Date October 01, 1999
Days to Decision 44 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
63d faster than avg
Panel avg: 107d · This submission: 44d
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 97
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K992775.
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · Norland Medical Systems, Inc. · May 2000
PRODIGY LATERAL VIEW SOFTWARE
K000826 · Lunar Corp. · Apr 2000
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · Norland Medical Systems, Inc. · Nov 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246 · Image Analysis, Inc. · Sep 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992677 · Hologic, Inc. · Sep 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · Compumed, Inc. · May 1999