Cleared Special

K021331 - DEXACARE G4

K021331 is an FDA 510(k) clearance for DEXACARE G4, manufactured by Osteometer Meditech, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Special 510(k) pathway after a 25-day FDA review.

K021331 · Osteometer Meditech, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
25d
Days
Class 2
Risk

K021331 is an FDA 510(k) clearance for the DEXACARE G4. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Osteometer Meditech, Inc. (Hawthorne, US). The FDA issued a Cleared decision on May 21, 2002 after a review of 25 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 - K021331

510(k) Number K021331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date May 21, 2002
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 144
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K021331.
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K021331 · DEXACARE G4
Download PDF FDA Summary Osteometer Meditech, …