FDA.reportPublic FDA data

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80302333002808139SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION1N2026-01-011,NISHINOKYO KUWABARA-CHO NAKAGYO-KU KYOTO JP 604-8511

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
104821182874945K943545CEILING SUSPENDED C-ARM SUPPORT MH-100IZI1995-02-03
104821836597725K920725COLLIMATOR F-20IZW1992-04-16
104821081263772K252099TriniasOWB2026-03-24
104821174181728K240827SET-5002KPS2024-05-24
104821628542317K233722RADspeed ProKPR2024-02-23
104822067642151K233719FDR Visionary SuiteKPR2024-03-28
104821748689330K221922TriniasOWB2022-07-28
104821278173717K203535TriniasOWB2021-04-28
104821171784433K191877FLUOROspeedJAA2019-08-05
104821388601407K173517RADspeed fitKPR2018-03-30
104821542124823K152294FDR Visionary SuiteKPR2016-07-15
104822054452154K152244RADspeed ProKPR2016-06-20
104821445179453K142341X-RAY TV SYSTEM SONIALVISION G4JAA2015-03-06
104821670666361K131075X-RAY TV SYSTEM SONIAL VISION G4JAA2014-03-28
104821752750948K123508TRINIASOWB2014-02-26
104821486598628K101039SHIMADZU COLLIMATOR R-300IZW2010-09-20
104821922838454K101036SHIMADZU COLLIMATOR R-20JIZX2010-08-26
104821725223904K090578SHIMADZU COLLIMATOR R-30HIZW2009-11-06
104821170926727K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONIZL2009-06-30
104821660356495K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZL2008-05-14
104821304416245K072006DAR-9400FIZI2007-08-31
104821502678595K062360BRANSIST SAFIREIZI2006-10-05
104821799071603K052500DAR-8000FIZI2005-10-17
104821127760587K052076DAR-8000IIZI2005-09-02
104821985662713K050925DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIREMQB2005-06-01
104821182505663K043379SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200OXO2005-02-17
104821957891029K041763SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIESIZL2004-07-13
104821288374022K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HSJAA2004-05-17
104821889995491K033184LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400IZI2003-12-09
104821417161556K032443DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIREIZI2004-02-20
104821949968093K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LMJAA2001-10-18
104821200921400
104821319982202
104821419871279
104821837341051
104821855824929
104821899059790

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZI72007-08-31
KPR52024-03-28
JAA52019-08-05
OWB42026-03-24
IZW32010-09-20
IZL32009-06-30
KPS12024-05-24
IZX12010-08-26
MQB12005-06-01
OXO12005-02-17

PMN#