Cleared Traditional

K883280 - HOLOGIC QDR-1000 X-RAY BONE DENSITOMETE...

K883280 is an FDA 510(k) clearance for HOLOGIC QDR-1000 X-RAY BONE DENSITOMETE..., 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 57-day FDA review.

K883280 · Hologic, Inc. · Radiology device
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Sep 1988
Decision
57d
Days
Class 2
Risk

K883280 is an FDA 510(k) clearance for the HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 57 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 - K883280

510(k) Number K883280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1988
Decision Date September 29, 1988
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 K883280.
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
K901854 · Amersham Corp. · Jul 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
K901857 · Amersham Corp. · Jul 1990
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · Hologic, Inc. · Dec 1989
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · Hologic, Inc. · Sep 1988
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446 · Hologic, Inc. · Oct 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553 · Hologic, Inc. · Oct 1987