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
2118291481395238K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHX2022-04-12
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
MHX32022-04-13
JAK32021-12-17
LNH32017-03-17
IZL22021-04-28
KPR22019-07-24