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DexaCare G4

by Osteometer Meditech, Inc.

510(k) K021331

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK021331 Date21 May 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KGI
Device Class
Class II
Regulation
21 CFR Part 892.1170
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DexaCare G4 is a dual-energy X-ray absorptiometry (DXA) densitometer designed for measuring bone mineral density in radiology settings. It provides quantitative assessment of bone health, particularly for diagnosing osteoporosis and monitoring bone metabolism in clinical environments.

This device is supplied as a standalone system for office-based use and is intended for single-patient examinations. It operates under FDA 510(k) clearance (K021331) as a Class II medical device, adhering to regulatory standards for radiology applications. Multiple model variants are listed under registration numbers, ensuring compatibility with various clinical workflows.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications is the DexaCare G4 primarily used for in radiology settings?

    The DexaCare G4 is specifically designed for measuring bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA). It is primarily used to diagnose osteoporosis, assess bone health, and monitor bone metabolism in clinical environments. This quantitative assessment helps clinicians evaluate fracture risk and track changes in bone density over time.

  • Is the DexaCare G4 intended for single-use or repeated use in a clinical setting?

    The DexaCare G4 is supplied as a standalone system for office-based use and is intended for single-patient examinations. While the device itself is not disposable, it is configured for sequential use with individual patients in a clinical workflow, ensuring hygiene and accuracy for each assessment.

  • How many model variants of the DexaCare G4 are available, and are they all compatible with standard radiology workflows?

    The DexaCare G4 includes multiple model variants, each listed under distinct registration numbers (e.g., 3008921184, 3031503890, etc.). These variants are designed to accommodate various clinical workflows while adhering to regulatory standards for radiology applications, ensuring flexibility for different office-based settings.

  • What regulatory pathway does the DexaCare G4 follow, and what does this mean for its use in clinical practice?

    The DexaCare G4 follows the FDA 510(k) clearance pathway (K021331) as a Class II medical device under the Radiology advisory committee. This means it has been determined to be substantially equivalent to a predicate device and meets FDA regulatory standards for DXA densitometers, ensuring its safety and effectiveness for measuring bone mineral density in clinical practice.