Shimadzu Medical Systems

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
90
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0868-2022Class IIMODEL: X-RAY TV SYSTEM SONIALVISION G4January 10, 2022
Z-0867-2022Class IIMODEL: X-RAY R/F SYSTEM FLUOROspeed X1January 10, 2022
Z-0869-2022Class IIMODEL: X-RAY TV SYSSTEM SONIALVISION safire17January 10, 2022
Z-0654-2022Class IIDigital Angiography System Bransist safire Generator Model D150GC-40December 16, 2021
Z-0655-2022Class IIDigital Angiography System Shimadzu Trinias Generator Model: D150GC-40December 16, 2021
Z-0555-2021Class IITrinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product UNovember 18, 2020
Z-0554-2021Class IIBransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - PrNovember 18, 2020
Z-0556-2021Class IIMH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiNovember 18, 2020
Z-0534-2021Class IIShimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, MadNovember 9, 2020
Z-2591-2020Class IITrinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - November 4, 2019
Z-2060-2018Class IISonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system deviceJanuary 12, 2018
Z-0917-2017Class IIShimadzu X-ray TV System, Catalog No. SONIALVISION G4November 20, 2016
Z-0918-2017Class IIShimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with November 20, 2016
Z-1585-2016Class IIX-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, March 31, 2016
Z-0451-2016Class IIMobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and November 10, 2015
Z-0251-2016Class IIShimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.September 30, 2015
Z-1569-2014Class IIShimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be uApril 3, 2014
Z-1150-2014Class IIMobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray systemNovember 15, 2013
Z-1369-2013Class IIShimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to takMarch 18, 2013
Z-0265-2013Class II0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take geOctober 28, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICDecember 15, 2008
K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROJanuary 9, 2008
K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROJanuary 9, 2008
K071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100January 9, 2008
K061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROJuly 27, 2006
K061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PROJuly 25, 2006
K061641ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANOJuly 14, 2006
K052500DAR-8000FOctober 17, 2005
K052076DAR-8000ISeptember 2, 2005
K050510ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100April 1, 2005
K003514ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200February 12, 2001
K003515ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200February 12, 2001
K994431SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIESMarch 23, 2000
K984156SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTIONApril 21, 1999
K980837SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TSMay 20, 1998
K973802SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEMMarch 4, 1998
K973329SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXOctober 8, 1997
K973327SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800THOctober 8, 1997
K970508ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEMAugust 4, 1997
K963888C-ARM TABLE IVS-100December 18, 1996