Shimadzu Medical Systems
Shimadzu Medical Systems holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2008, with 26 FDA device recalls on record.
Top product codes for Shimadzu Medical Systems
FDA recalls by Shimadzu Medical Systems
10 most recent of 26- Z-2294-2026 — Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S
- Z-0869-2022 — MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
- Z-0868-2022 — MODEL: X-RAY TV SYSTEM SONIALVISION G4
- Z-0867-2022 — MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
- Z-0654-2022 — Digital Angiography System Bransist safire Generator Model D150GC-40
- Z-0655-2022 — Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
- Z-0554-2021 — Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
- Z-0555-2021 — Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Z-0556-2021 — MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Z-0534-2021 — Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Shimadzu Medical Systems
- K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
- K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
- K061641 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
- K052500 — DAR-8000F
- K052076 — DAR-8000I
- K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K003514 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
- K003515 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
- K994431 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
- K984156 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
- K980837 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
- K973802 — SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
- K973327 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
- K973329 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
- K970508 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
- K963888 — C-ARM TABLE IVS-100
- K963617 — SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
- K953634 — SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
- K955255 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
- K955253 — SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
- K955254 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
- K955395 — DAR-2400-15B/30B
- K936236 — SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
- K951315 — CATHETERIZATION TABLE KS-60
- K945452 — UD 150L-F
- K945453 — UD 150L-R II
- K943545 — CEILING SUSPENDED C-ARM SUPPORT MH-100
- K942669 — SMT-50CX/H
- K931021 — SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.
- K932244 — SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
- K923984 — SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM
- K925107 — SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
- K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES
- K925169 — SHIMADZU RADIOGRAPJHIC STAND BR-100
- K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100
- K925175 — SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
- K923453 — SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES
- K923454 — SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES
- K922012 — SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES
- K922011 — SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES
- K922013 — SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
- K920726 — UROLOGICAL X-RAY TABLE HS-10A
- K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
- K920728 — X-RAY DIAGNOSTIC TABLE YSF-100
- K921432 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
- K920723 — HIGH SPEED ROTATION STARTER SA-40
- K920724 — HIGH SPEED ROTATION STARTER SA-50
- K920729 — BUCKY TABLE BK-12
- K920730 — X-RAY HIGH VOLTAGE GENERATOR ED 125L
- K920720 — DIGITAL RADIOGRAPHY SYSTEM IDR-1000
- K920725 — COLLIMATOR F-20
- K920727 — CEILING TUBE SUPPORT CH-30X
- K920732 — CATHERIZATION KS-50
- K920733 — STEREO COLLIMATOR RF-T SERIES
- K920721 — DIGITAL RADIOGRAPHY SYSTEM IDR-2000
- K920387 — CIRCLEXO.3T X-RAY TUBE ASSEMBLY
- K920722 — X-RAY DIAGNOSTIC TABLE YSF-200-30-90
- K920393 — MU125M MOBILE X-RAY SYSTEM
- K915623 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
- K914348 — ER-1000 CATHERIZATION C-ARM SYSTEMS
- K911975 — SMT-100X
- K913147 — SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
- K913062 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
- K913063 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
- K913064 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
- K913065 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
- K911500 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
- K911501 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
- K911280 — SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
- K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
- K905132 — SHIMADZU IMAGE PROCESSOR DFS-500
- K911339 — SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
- K905634 — SMT-50X
- K903941 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
- K905152 — REMOTE CONTROLLED X-RAY DIAG. RSZ-200
- K905153 — REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
- K903371 — CATHETERIZATION C-ARM SUPPORT MH-51B(F)
- K903372 — CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
- K903373 — CATHETERIZATION C-ARM SUPPORT MH-51C(F)
- K903942 — SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
- K894888 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
- K894887 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
- K894056 — POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
- K893744 — SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
- K895188 — SHIMADZU X-RAY TUBE STAND FH-31
- K893637 — MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.