Shimadzu Medical Systems
FDA Regulatory Profile
Shimadzu Medical Systems appears in FDA public data with 26 recalls, 90 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2294-2026, Class II) was initiated on April 20, 2026. Its most recent 510(k) clearance was granted on December 15, 2008.
Summary
- Total Recalls
- 26
- 510(k) Clearances
- 90
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2294-2026 | Class II | Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire | April 20, 2026 |
| Z-0868-2022 | Class II | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | January 10, 2022 |
| Z-0867-2022 | Class II | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | January 10, 2022 |
| Z-0869-2022 | Class II | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | January 10, 2022 |
| Z-0655-2022 | Class II | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | December 16, 2021 |
| Z-0654-2022 | Class II | Digital Angiography System Bransist safire Generator Model D150GC-40 | December 16, 2021 |
| Z-0554-2021 | Class II | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Pr | November 18, 2020 |
| Z-0556-2021 | Class II | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardi | November 18, 2020 |
| Z-0555-2021 | Class II | Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product U | November 18, 2020 |
| Z-0534-2021 | Class II | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Mad | November 9, 2020 |
| Z-2591-2020 | Class II | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - | November 4, 2019 |
| Z-2060-2018 | Class II | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device | January 12, 2018 |
| Z-0918-2017 | Class II | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with | November 20, 2016 |
| Z-0917-2017 | Class II | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | November 20, 2016 |
| Z-1585-2016 | Class II | X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, | March 31, 2016 |
| Z-0451-2016 | Class II | Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and | November 10, 2015 |
| Z-0251-2016 | Class II | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | September 30, 2015 |
| Z-1569-2014 | Class II | Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be u | April 3, 2014 |
| Z-1150-2014 | Class II | Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system | November 15, 2013 |
| Z-1369-2013 | Class II | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to tak | March 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | December 15, 2008 |
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | January 9, 2008 |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | January 9, 2008 |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | January 9, 2008 |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | July 27, 2006 |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | July 25, 2006 |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | July 14, 2006 |
| K052500 | DAR-8000F | October 17, 2005 |
| K052076 | DAR-8000I | September 2, 2005 |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | April 1, 2005 |
| K003515 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 | February 12, 2001 |
| K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | February 12, 2001 |
| K994431 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES | March 23, 2000 |
| K984156 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION | April 21, 1999 |
| K980837 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS | May 20, 1998 |
| K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | March 4, 1998 |
| K973327 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH | October 8, 1997 |
| K973329 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX | October 8, 1997 |
| K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM | August 4, 1997 |
| K963888 | C-ARM TABLE IVS-100 | December 18, 1996 |