Shimadzu Medical Systems
Long Beach, CA, US
SHIMADZU MEDICAL SYSTEMS appears in FDA device records in Long Beach, CA. FDA records list 90 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Shimadzu Medical Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Shimadzu Medical Systems Usa Comenforcement report, recall
510(k) clearance history
Showing 50 of 90FDA records hold 90 510(k) clearances for Shimadzu Medical Systems between 1989 and 2008. The busiest year on record is 1992, with 27. The most recent is 2008, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 5 |
| 1990 | 7 |
| 1991 | 15 |
| 1992 | 27 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 7 |
| 1996 | 6 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2005 | 3 |
| 2006 | 3 |
| 2008 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | ITX | Substantially Equivalent | |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | ITX | Substantially Equivalent | |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | ITX | Substantially Equivalent | |
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | ITX | Substantially Equivalent | |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | IYN | Substantially Equivalent | |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | IYN | Substantially Equivalent | |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | IYO | Substantially Equivalent | |
| K052500 | DAR-8000F | IZI | Substantially Equivalent | |
| K052076 | DAR-8000I | IZI | Substantially Equivalent | |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | IYN | Substantially Equivalent | |
| K003515 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 | IYN | Substantially Equivalent | |
| K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | IYN | Substantially Equivalent | |
| K994431 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES | JAK | Substantially Equivalent | |
| K984156 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION | JAK | Substantially Equivalent | |
| K980837 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS | JAK | Substantially Equivalent | |
| K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K973329 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX | JAK | Substantially Equivalent | |
| K973327 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH | JAK | Substantially Equivalent | |
| K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K963888 | C-ARM TABLE IVS-100 | JAA | Substantially Equivalent | |
| K963617 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 | JAA | Substantially Equivalent | |
| K953634 | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K955255 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX | JAK | Substantially Equivalent | |
| K955254 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC | JAK | Substantially Equivalent | |
| K955253 | SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH | JAK | Substantially Equivalent | |
| K955395 | DAR-2400-15B/30B | IZI | Substantially Equivalent | |
| K951315 | CATHETERIZATION TABLE KS-60 | IZZ | Substantially Equivalent | |
| K936236 | SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES | JAA | Substantially Equivalent | |
| K945453 | UD 150L-R II | IZO | Substantially Equivalent | |
| K945452 | UD 150L-F | IZO | Substantially Equivalent | |
| K943545 | CEILING SUSPENDED C-ARM SUPPORT MH-100 | IZI | Substantially Equivalent | |
| K942669 | SMT-50CX/H | LNH | Substantially Equivalent | |
| K931021 | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. | IYO | Substantially Equivalent | |
| K932244 | SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K923984 | SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K925107 | SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | IYB | Substantially Equivalent | |
| K925169 | SHIMADZU RADIOGRAPJHIC STAND BR-100 | KPX | Substantially Equivalent | |
| K925175 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 | IXR | Substantially Equivalent | |
| K925174 | SHIMADZU RADIOGRAPHIC TABLE BK-100 | IZZ | Substantially Equivalent | |
| K923454 | SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES | JAA | Substantially Equivalent | |
| K923453 | SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES | JAA | Substantially Equivalent | |
| K922012 | SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES | JAA | Substantially Equivalent | |
| K922013 | SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES | JAA | Substantially Equivalent | |
| K922011 | SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES | JAA | Substantially Equivalent | |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | ITY | Substantially Equivalent | |
| K920726 | UROLOGICAL X-RAY TABLE HS-10A | IXR | Substantially Equivalent | |
| K921432 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF | JAK | Substantially Equivalent | |
| K920728 | X-RAY DIAGNOSTIC TABLE YSF-100 | IXR | Substantially Equivalent | |
| K920730 | X-RAY HIGH VOLTAGE GENERATOR ED 125L | IZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000125362 | 1000125362 | SHIMADZU MEDICAL SYSTEMS | 3645 N Lakewood Blvd, Long Beach, CA 90808 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- KPXChanger, Radiographic Film/Cassette
- IZWCollimator, Automatic, Radiographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- HEMImager, Ultrasonic Obstetric-Gynecologic
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- IZGSystem, X-Ray, Photofluorographic
- JAKSystem, X-Ray, Tomography, Computed
- IZZTable, Radiographic, Non-Tilting, Powered
- IXQTable, Radiographic, Stationary Top
- IXRTable, Radiographic, Tilting
- ITXTransducer, Ultrasonic, Diagnostic
- IYBTube Mount, X-Ray, Diagnostic
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. | Class II | Open, Classified | |
| Z-0869-2022 | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. | Class II | Open, Classified | |
| Z-0868-2022 | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. | Class II | Open, Classified | |
| Z-0867-2022 | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. | Class II | Open, Classified | |
| Z-0655-2022 | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode. | Class II | Open, Classified | |
| Z-0654-2022 | Digital Angiography System Bransist safire Generator Model D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode. | Class II | Open, Classified | |
| 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. | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator. | Class II | Open, Classified | |
| 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. | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator. | Class II | Open, Classified | |
| 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. | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator. | Class II | Open, Classified | |
| 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. | There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device. | Class II | Open, Classified | |
| Z-2591-2020 | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology. | The DAP meters were found to be outside of tolerance. | Class II | Completed | |
| Z-0864-2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. | Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment. | Class II | Terminated | |
| Z-0959-2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices. | Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. | Class II | Terminated | |
| Z-1039-2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This 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. Exposure can be captured on film, CR or Digital Radiography (DR). | In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast. | Class II | Terminated | |
| Z-0197-2019 | TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel. | Class II | Terminated | |
| Z-2060-2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population. | When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event. | Class II | Terminated | |
| Z-2655-2017 | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Terminated | |
| Z-2654-2017 | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Terminated | |
| Z-2653-2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Terminated | |
| Z-0918-2017 | 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. | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions. | Class II | Terminated | |
| Z-0917-2017 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions. | Class II | Terminated | |
| Z-1585-2016 | 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 | Report of unintentional movement of table to reverse tilting. | Class II | Terminated | |
| Z-0451-2016 | 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. | The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly. | Class II | Terminated | |
| Z-0251-2016 | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | The C-arm may interfere with the table top under certain circumstances. | Class II | Terminated | |
| Z-1569-2014 | 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. | Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain