Cleared Traditional

K961007 - EXPERT SPINE MORPHOTIETRY REFERENCE

K961007 is an FDA 510(k) clearance for EXPERT SPINE MORPHOTIETRY REFERENCE, manufactured by Lunar Corp.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K961007 · Lunar Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
135d
Days
Class 2
Risk

K961007 is an FDA 510(k) clearance for the EXPERT SPINE MORPHOTIETRY REFERENCE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 135 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 Corp. devices

FDA 510(k) Submission Details - K961007

510(k) Number K961007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date July 25, 1996
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
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 64
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K961007.
PIXI BONE DENSITOMETER
K970224 · Lunar Corp. · Apr 1997
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363 · Hologic, Inc. · Nov 1996
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263 · Lunar Corp. · Nov 1996
LUNAR REPORT GENERATOR
K961944 · Lunar Corp. · Jul 1996
LUNAR DPX DENSITOMETER
K953032 · Lunar Corp. · Oct 1995
BONE MINERAL DENSITOMETER
K941362 · Hologic, Inc. · Aug 1995