510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shimadzu Corp.

Torrance, CA, US

Shimadzu Corp. appears in FDA device records in Torrance, CA. FDA records list 58 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
58
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 58

FDA records hold 58 510(k) clearances for Shimadzu Corp. between 1979 and 2026. The busiest year on record is 1993, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shimadzu Corp., by decision year
YearClearances
19791
19831
19842
19851
19861
19882
19891
19903
19934
19944
19954
19971
19981
19992
20001
20012
20032
20044
20052
20061
20072
20081
20092
20102
20142
20151
20162
20181
20192
20242
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252099TriniasOWBSubstantially Equivalent
K233719FDR Visionary SuiteKPRSubstantially Equivalent
K233722RADspeed ProKPRSubstantially Equivalent
K191877FLUOROspeedJAASubstantially Equivalent
K190373SonialVision G4JAASubstantially Equivalent
K173517RADspeed fitKPRSubstantially Equivalent
K152294FDR Visionary SuiteKPRSubstantially Equivalent
K152244RADspeed ProKPRSubstantially Equivalent
K142341X-RAY TV SYSTEM SONIALVISION G4JAASubstantially Equivalent
K131075X-RAY TV SYSTEM SONIAL VISION G4JAASubstantially Equivalent
K123508TRINIASOWBSubstantially Equivalent
K101039SHIMADZU COLLIMATOR R-300IZWSubstantially Equivalent
K101036SHIMADZU COLLIMATOR R-20JIZXSubstantially Equivalent
K090578SHIMADZU COLLIMATOR R-30HIZWSubstantially Equivalent
K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONIZLSubstantially Equivalent
K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZLSubstantially Equivalent
K072006DAR-9400FIZISubstantially Equivalent
K071717GE OEC ALTITUDEIZISubstantially Equivalent
K062360BRANSIST SAFIREIZISubstantially Equivalent
K050925DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIREMQBSubstantially Equivalent
K043379SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200OXOSubstantially Equivalent
K042840SHIMADZU COLLIMATOR R-20JIZXSubstantially Equivalent
K041763SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIESIZLSubstantially Equivalent
K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HSJAASubstantially Equivalent
K032443DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIREIZISubstantially Equivalent
K033184LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400IZISubstantially Equivalent
K031771SHIMADZU COLLIMATOR R-30HIZXSubstantially Equivalent
K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LMJAASubstantially Equivalent
K011141SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TCJAKSubstantially Equivalent
K001517SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIESIZLSubstantially Equivalent
K991553SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTIONJAKSubstantially Equivalent
K990715SHIMADZU CEILING TUBE SUPPORT CH-30GHKPRSubstantially Equivalent
K982583SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXLJAKSubstantially Equivalent
K973342DAR-3000BIZISubstantially Equivalent
K955036MOBILE X-RAY SYSTEMIZLSubstantially Equivalent
K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GIZOSubstantially Equivalent
K945389IVR MASTERLLZSubstantially Equivalent
K945388DFS-700LLZSubstantially Equivalent
K942731SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GRIZOSubstantially Equivalent
K942792BUCKY STAND BR-10MKPRSubstantially Equivalent
K935487SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TFJAKSubstantially Equivalent
K933472SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIESJAASubstantially Equivalent
K934967SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATORIZOSubstantially Equivalent
K934005SHIMADZU CEILING TUBE SUPPORT CH-30GXKPRSubstantially Equivalent
K933473CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CMJAASubstantially Equivalent
K933471SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150GIZOSubstantially Equivalent
K897073ADDITIONAL TRANSDUCERS FOR USE W/SDL 300ITXSubstantially Equivalent
K896644ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500ITXSubstantially Equivalent
K896999SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENTIYOSubstantially Equivalent
K895394MOBILE X-RAY TELEVISION UNIT WHA-10A/BJAASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain