Cleared Traditional

K981124 - ACCUDEXA BONE DENSITOMETER

K981124 is an FDA 510(k) clearance for ACCUDEXA BONE DENSITOMETER, manufactured by Schick Technologies, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K981124 · Schick Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
69d
Days
Class 2
Risk

K981124 is an FDA 510(k) clearance for the ACCUDEXA BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Rockville, US). The FDA issued a Cleared decision on June 4, 1998 after a review of 69 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 Schick Technologies, Inc. devices

FDA 510(k) Submission Details - K981124

510(k) Number K981124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1998
Decision Date June 04, 1998
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 107d · This submission: 69d
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 69
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K981124.
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271 · Lunar Corp. · Nov 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K983028 · Hologic, Inc. · Nov 1998
DPX-RX BONE DENSITOMETER
K982267 · Lunar Corp. · Aug 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437 · Lunar Corp. · Feb 1998
NORLAND MODEL PDEXA BONE DENSITOMETER
K973104 · Norland Corp. · Jan 1998
ACCUDEXA BONE DENSITOMETER
K971735 · Schick Technologies, Inc. · Dec 1997