FDA.reportPublic FDA data

Repair Operations Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136795583013679558Repair Operations Center1Y2026-01-01120 Opus Drive Oak Creek WI US 53154

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2118291074908898K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex editionJAK2021-12-17
2118291771137171K213363CARESCAPE B450, E-musbMHX2022-04-13
2118291513812715K213181CARESCAPE B650, E-musbMHX2022-04-13
2118291860639661K210982AMX NavigateIZL2021-04-28
2118291592295961K191699Discovery XR656 HD with VolumeRadKPR2019-07-24
2118291095301138K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistLNH2017-03-17
2118291246122195K162990Optima XR240amxIZL2016-11-15
2118291515159878K132410DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 WJAK2014-01-17
2118291510863412K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
2118291196014947K113490OPTIMA MR450WLNH2012-01-13
2118291718531484K111445DISCOVERY NM 630KPS2011-06-03
2118291835270846K061817LIGHTSPEED 7.1 CT SCANNER SYSTEMJAK2006-07-12
2118291398524574K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISKPR2005-08-09
2118291420785396K041543GE DISCOVERY STKPS2004-06-22
2118291431615508K030199GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEMKPS2003-02-11
2118291050683036K022872GE ROAD WARRIOR PET CT IMAGING SYSTEMKPS2002-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS42011-06-03
JAK32021-12-17
LNH32017-03-17
MHX22022-04-13
IZL22021-04-28
KPR22019-07-24