Cleared Traditional

K974437 - EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE

K974437 is an FDA 510(k) clearance for EXPERT-XL LATERAL SPINE BMD ACQUISITION..., 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 81-day FDA review.

K974437 · Lunar Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
81d
Days
Class 2
Risk

K974437 is an FDA 510(k) clearance for the EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 81 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 Corp. devices

FDA 510(k) Submission Details - K974437

510(k) Number K974437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date February 13, 1998
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
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 108
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K974437.
ACCUDEXA BONE DENSITOMETER
K981124 · Schick Technologies, Inc. · Jun 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125 · Norland Corp. · May 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459 · Norland Corp. · Feb 1998
NORLAND MODEL PDEXA BONE DENSITOMETER
K973104 · Norland Corp. · Jan 1998
ACCUDEXA BONE DENSITOMETER
K971735 · Schick Technologies, Inc. · Dec 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · Lunar Corp. · Nov 1997