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Encore Version 16 Software for GE Lunar Dxa Bone Densitometers

by Ge Medical Systems Ultrasound & Primary Care Diagn

510(k) K133664

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK133664 Date15 May 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1710-2020 FDA Class II initiated 3 Dec 2019

    An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

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  • Withdrawn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