Cleared Special

K001429 - MODIFICATION TO ACCUDEXA BONE DENSITOMETER

K001429 is an FDA 510(k) clearance for MODIFICATION TO ACCUDEXA BONE DENSITOMETER, manufactured by Schick Technologies, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Special 510(k) pathway after a 21-day FDA review.

K001429 · Schick Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
21d
Days
Class 2
Risk

K001429 is an FDA 510(k) clearance for the MODIFICATION TO ACCUDEXA BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Long Island City, US). The FDA issued a Cleared decision on May 26, 2000 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001429

510(k) Number K001429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2000
Decision Date May 26, 2000
Days to Decision 21 days
Submission Type Special
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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 124
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K001429.
PEDIATRIC REFERENCE DATA
K001812 · Lunar Corp. · Jul 2000
LUNAR REPORT GENERATOR II
K001756 · Lunar Corp. · Jul 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176 · Norland Medical Systems, Inc. · Jun 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · Norland Medical Systems, Inc. · May 2000
METRISCAN BONE DENSITY SYSTEM
K000162 · Alara, Inc. · May 2000
PRODIGY LATERAL VIEW SOFTWARE
K000826 · Lunar Corp. · Apr 2000
K001429 · MODIFICATION TO ACCUDEXA BONE DENSITOMETER
Download PDF FDA Summary Schick Technologies, …