Cleared Traditional

K914404 - ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT

K914404 is an FDA 510(k) clearance for ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/D..., manufactured by Lunar. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K914404 · Lunar · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
147d
Days
Class 2
Risk

K914404 is an FDA 510(k) clearance for the ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar (Madison, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 147 days - within the typical 510(k) review window.

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 - K914404

510(k) Number K914404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date February 27, 1992
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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 K914404.
LUNAR EXPERT
K945526 · Lunar Corp. · Apr 1995
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 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