Cleared Traditional

K905753 - QDR-1000 AND QDR-1000/W X-RAY BONE DENS...

K905753 is an FDA 510(k) clearance for QDR-1000 AND QDR-1000/W X-RAY BONE DENS..., 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 168-day FDA review.

K905753 · Hologic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
168d
Days
Class 2
Risk

K905753 is an FDA 510(k) clearance for the QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 168 days - an extended review 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: 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

FDA 510(k) Submission Details - K905753

510(k) Number K905753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date June 10, 1991
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
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 K905753.
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505 · Hologic, Inc. · Jan 1995
DTX-100
K926300 · Hologic, Inc. · Jul 1993
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · Hologic, Inc. · Nov 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · Hologic, Inc. · May 1991
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · Hologic, Inc. · Aug 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
K901832 · Amersham Corp. · Jul 1990