Cleared Traditional

K904980 - DPX-L AND DPX-ALPHA, MODIFICATION

K904980 is an FDA 510(k) clearance for DPX-L AND DPX-ALPHA, manufactured by Lunar. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K904980 · Lunar · Radiology device
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Dec 1990
Decision
33d
Days
Class 2
Risk

K904980 is an FDA 510(k) clearance for the DPX-L AND DPX-ALPHA, MODIFICATION. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar (Madison, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 33 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 Lunar devices

FDA 510(k) Submission Details - K904980

510(k) Number K904980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date December 05, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
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 K904980.
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · Hologic, Inc. · Nov 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · Hologic, Inc. · Jun 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
GADOLINIUM-153 BONE DENSITOMETER SOURCES
K901848 · Amersham Corp. · Jul 1990