FDA.reportPublic FDA data

GE OEC MEDICAL SYSTEMS, INC

Matched from indexed company URL: Ge Oec Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17207531720753GE OEC MEDICAL SYSTEMS, INC1Y2026-01-01384 N WRIGHT BROTHERS DR SALT LAKE CITY UT US 84116

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266531569320109K993687UROVIEW 2800OWB1999-12-21
266531917174853K992506MINI 6800 DIGITAL MOBILE C-ARMOXO1999-08-19
266531380220467K983529INSTATRAK 3000LLZ1998-12-31
266531084038149K981998PEDIATRIC INSTATRAK SYSTEMLLZ1998-08-21
266531952618285K974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)OWB1998-02-17
266531087033553K963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEMOWB1996-12-23
266531098404298K960330INSTATRAKLLZ1996-04-08
266532052516530K951765SERIES 6600 DIGITAL MOBILE C-ARMOXO1995-05-11
266531332283773K940295UROVIEW MODEL 2600JAA1994-08-22
266531152821863K933447STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEMOXO1993-08-23
266531607179219K9260569600 FLUOROSCOPIC IMAGING SYSTEMOXO1993-01-21
266531172499898K233669OEC 3DOXO2024-03-28
266531573388248K203346OEC 3DOXO2021-03-05
266531088178698K192819OEC EliteOXO2019-11-08
266531623499834K172550OEC EliteOXO2017-11-16
266532030526179K171800OEC Elite MiniViewOXO2017-07-12
266531675312227K171565OEC EliteOWB2017-08-10
266531116091442K170752OEC EliteOWB2017-05-19
266531576910601K160131OEC Elite MiniViewOXO2016-06-21
266531254178403K132027OEC 9800 PLUSOWB2014-05-01
266531872604136K122234OEC 9900 ELITEOWB2012-08-16
266531979744854K120613OEC 9900 ELITEOXO2012-04-06
266531810807511K111551OEC(R) 9800, OEC(R) 9800 PLUSOWB2011-10-04
266531941637617K082781OEC 9900 ELITEOWB2009-05-01
266531655951537K073543OEC 9900 ELITEOWB2008-05-02
266531467018841K0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSOWB2006-08-15
266531292161007K051734GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955HAW2005-11-23
266531128680777K041932OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEMOWB2004-08-18
266531049681439K041931OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATIONOWB2004-08-26
266531717830943K040050INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500LLZ2004-03-24
266531532852488K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMJAA2003-03-20
266531151733165K022069OEC FLUOROTRAK 9800 PLUSOWB2002-09-17
266531445527125K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMOWB2002-04-17
266531027321088
266531221664841
266531329600799
266531286585299
266532029320098

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWB152017-08-10
OXO112024-03-28
LLZ42004-03-24
JAA22003-03-20
HAW12005-11-23

PMN#

OEC 3D

2024-03-28

Ge Oec Medical Systems, Inc.

OEC 3D

2021-03-05

GE OEC Medical Systems, Inc.

OEC Elite

2019-11-08

GE OEC Medical Systems, Inc.

OEC Elite

2017-11-16

GE OEC Medical Systems, Inc.

OEC Elite

2017-08-10

GE OEC Medical Systems, Inc.