39 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
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
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·June 10, 2026
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 14, 2012
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·April 13, 2022
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·April 13, 2022
MODEL: X-RAY TV SYSTEM SONIALVISION G4
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·April 13, 2022
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·March 12, 2014
Digital Angiography System Bransist safire Generator Model D150GC-40
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·March 9, 2022
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·March 9, 2022
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·June 12, 2013
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·May 14, 2014
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·November 18, 2015
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·December 30, 2015
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·May 4, 2016