Cleared Traditional

K964263 - EXPERT-KL AND HAND ACQUISITION AND ANAL...

K964263 is an FDA 510(k) clearance for EXPERT-KL AND HAND ACQUISITION AND ANAL..., 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 13-day FDA review.

K964263 · Lunar Corp. · Radiology device
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Nov 1996
Decision
13d
Days
Class 2
Risk

K964263 is an FDA 510(k) clearance for the EXPERT-KL AND HAND 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 November 7, 1996 after a review of 13 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 - K964263

510(k) Number K964263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date November 07, 1996
Days to Decision 13 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
94d faster than avg
Panel avg: 107d · This submission: 13d
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 K964263.
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