Cleared Traditional

K970224 - PIXI BONE DENSITOMETER

K970224 is an FDA 510(k) clearance for PIXI BONE DENSITOMETER, 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 85-day FDA review.

K970224 · Lunar Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
85d
Days
Class 2
Risk

K970224 is an FDA 510(k) clearance for the PIXI BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 85 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 - K970224

510(k) Number K970224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 16, 1997
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 K970224.
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
K972053 · Lunar Corp. · Aug 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · Hologic, Inc. · Jun 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · 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
EXPERT SPINE MORPHOTIETRY REFERENCE
K961007 · Lunar Corp. · Jul 1996