510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133664Substantially Equivalent

Encore Version 16 Software for Ge Lunar Dxa Bone Densitometers

GE Medical Systems Ultrasound & Primary Care Diagn, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133664 is the FDA 510(k) clearance record for ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS, a class II device, cleared for Ge Medical Systems Ultrasound & Primary Care Diagn on under FDA product code KGI (Densitometer, Bone). FDA records list one 510(k) clearance for Ge Medical Systems Ultrasound & Primary Care Diagn. As of , FDA records show one recall naming K133664.

Clearance record

Decision date
Received
(167 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems Ultrasound & Primary Care Diagn 3030 Ohmeda Dr., Madison WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260