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Xr 46 Dxa (Central) Bone Densitometer, Model Xr 46

by Norland Medical Systems, Inc.

510(k) K992125

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK992125 Date22 Nov 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0213-2012 FDA Unclassified (pre-2012) initiated 23 Sep 2011

    The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record.

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  • Withdrawn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

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