Cleared Traditional

K884625 - DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY

K884625 is an FDA 510(k) clearance for DPX BONE DENSITOMETER FOR TOTAL BODY BO..., manufactured by Lunar. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K884625 · Lunar · Radiology device
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Jun 1989
Decision
231d
Days
Class 2
Risk

K884625 is an FDA 510(k) clearance for the DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar (Madison, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 231 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 Lunar devices

FDA 510(k) Submission Details - K884625

510(k) Number K884625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date June 23, 1989
Days to Decision 231 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 107d · This submission: 231d
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 103
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K884625.
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 QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · Hologic, Inc. · Sep 1988
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