Cleared Traditional

K964562 - DTX-200 BONE DENSITOMETER

K964562 is an FDA 510(k) clearance for DTX-200 BONE DENSITOMETER, manufactured by Osteometer Meditech A/S. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K964562 · Osteometer Meditech A/S · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
282d
Days
Class 2
Risk

K964562 is an FDA 510(k) clearance for the DTX-200 BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Osteometer Meditech A/S (Dallas, US). The FDA issued a Cleared decision on August 22, 1997 after a review of 282 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteometer Meditech A/S devices

FDA 510(k) Submission Details - K964562

510(k) Number K964562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date August 22, 1997
Days to Decision 282 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
175d slower than avg
Panel avg: 107d · This submission: 282d
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 K964562.
ACCUDEXA BONE DENSITOMETER
K971735 · Schick Technologies, Inc. · Dec 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · Lunar Corp. · Nov 1997
APOLLO
K972882 · Norland Corp. · Oct 1997
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