FDA.reportPublic FDA data

BLOCK IMAGING PARTS & SERVICE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30315038903031503890BLOCK IMAGING PARTS & SERVICE1Y2026-01-011845 Cedar St. Holt MI US 48842

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3247552026676585P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMMUE2000-01-28
3247551943952622P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
3247551491591249P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
3247551494998671K982265AQUILION CT SCANNER, MODEL TSX-101AJAK1998-08-26
3247551794421888K202238SIGNA ArtistLNH2020-09-04
3247551263717147K193178Biograph HorizonKPS2020-02-12
3247551112640846K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionJAK2019-07-26
3247551829357227K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNH2019-06-04
3247551510061537K190138MAGNETOM AeraLNH2019-02-15
3247551537215647K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OROWB2018-11-02
3247551223730069K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOJAK2018-04-13
3247551686616410K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM ConfidenceJAK2018-03-30
3247551864554927K172869Discovery XR656 HDKPR2017-10-20
3247551588437733K170752OEC EliteOWB2017-05-19
3247552001866575K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistLNH2017-03-17
3247551328159651K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3LNH2017-01-06
3247551674055805K162990Optima XR240amxIZL2016-11-15
3247551597543018K162268Senographe PristinaMUE2016-11-03
3247551828497395K161682GE Lunar DXA Bone Densitometers with enCORE version 17KGI2016-12-02
3247551611639477K161563Allura Xper FD series and Allura Xper OR Table seriesOWB2016-07-29
3247551574751246K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TLNH2016-06-09
3247551852849117K151765SOMATOM PerspectiveJAK2016-03-25
3247551929911444K151486Biograph mCT and mCT Flow PET/CT ScannersKPS2015-07-17
3247551564507933K143251SIGNA Creator, SIGNA ExplorerLNH2015-02-04
3247551920548382K142383Optima XR200amx, Optima XR220amxIZL2014-09-25
3247551506595851K142361Discovery MR750 3.0TLNH2014-12-05
3247551845585021K140253MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPELNH2014-03-20
3247551479917836K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSKGI2014-05-15
3247551175866939K132119MAGNETOM PRISMA, MAGNETOM PRISMA FITLNH2013-11-22
3247551292637743K131885SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)MUE2013-09-26
3247551063056198K131634SYMBIAKPS2013-08-16
3247551677768124K131576OPTIMA CT660JAK2013-08-30
3247551318673377K130885MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FITLNH2013-05-17
3247551737876469K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZI2013-05-21
3247551534140646K130115DISCOVERY MR750W 3.0TLNH2013-05-23
3247551449755911K123596OPTIMA CT520JAK2013-02-08
3247551756351935K122457GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONSOWB2013-01-02
3247551218352971K122234OEC 9900 ELITEOWB2012-08-16
3247551211851664K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
3247551689099801K120833DISCOVERY CT750 HDJAK2012-06-12
3247551978980776K120613OEC 9900 ELITEOXO2012-04-06
3247552042874778K111445DISCOVERY NM 630KPS2011-06-03
3247551676270657K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUE2011-12-22
3247551890337398K103127SOMATOM DEFINITION ASJAK2011-03-04
3247551056318264K091536OPTIMA MR450WLNH2009-07-17
3247551943927897K090745ARTIS ZEE / ZEEGOS WITH SW VC14IZI2009-06-18
3247551407339483K082816GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEMJAK2008-10-08
3247551057011285K082506SYMBIA, VERSION 4.0KPS2008-11-21
3247551759987216K081722YSIOKPR2008-08-22
3247551498254364K081496OPTIMA PET/CT 560KPS2008-06-12
3247551561575200K073543OEC 9900 ELITEOWB2008-05-02
3247551824661110K072567SYMBIA-E, MODEL 10275879KPS2007-10-30
3247551629868165K072237MAGNETOM VERIOLNH2007-10-10
3247551605108788K061817LIGHTSPEED 7.1 CT SCANNER SYSTEMJAK2006-07-12
3247551073344403K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMLNH2005-09-21
3247551463549481K052013ACHIEVA 1.5T & INERA 1.5T FAMILYLNH2005-08-02
3247551802923504K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISKPR2005-08-09
3247551150543499K051133ARCADIS AVANTICOXO2005-06-01
3247551002874749K050489INNOVA 2100OWB2005-03-11
3247551528078157K050297SOMATOM EMOTION 16JAK2005-03-01
3247551668223987K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
3247551010616447K042293BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNERJAK2004-09-08
3247551108686796K041949ALLURA XPER FD10IZI2004-07-30
3247551136424048K041543GE DISCOVERY STKPS2004-06-22
3247551600264248K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17
3247551973616475K041112MAGNETOM ESPREE SYSTEMLNH2004-07-21
3247551333583244K040372LIGHTSPEED 7.0 CT SCANNER SYSTEMJAK2004-03-01
3247551013422740K033737ALLURA XPER FD20OWB2003-12-09
3247551599821417K033168GE 0.2T SIGNA PROFILE/I MR SYSTEMLNH2003-10-10
3247551779638651K031637INNOVA 3100OWB2003-08-22
3247551266263659K030962DPX SERIES BRAVO DUO BONE DENSITOMETERKGI2003-07-25
3247551083965073K023398HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERYKGI2002-11-08
3247552037722579K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMOWB2002-04-17
3247551940791602

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH202020-09-04
JAK142019-07-26
OWB102018-11-02
KPS82020-02-12
MUE52016-11-03
KGI42016-12-02
KPR32017-10-20
IZI32013-05-21
IZL22016-11-15
OXO22012-04-06
OTE12011-02-11
DXT12004-12-10