Company ยท US
Shimadzu Medical Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2021. Name variants (Inc, Corp, punctuation) are merged.
91510(k) clearances (0 in 12 months)
26recalls (1 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 15 |
| JAK | System, X-Ray, Tomography, Computed | 14 |
| IZI | System, X-Ray, Angiographic | 13 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 11 |
| IZL | System, X-Ray, Mobile | 9 |
| IXR | Table, Radiographic, Tilting | 8 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 7 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 4 |
| IYB | Tube Mount, X-Ray, Diagnostic | 4 |
| IZW | Collimator, Automatic, Radiographic | 3 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 3 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| IXQ | Table, Radiographic, Stationary Top | 1 |
| IZG | System, X-Ray, Photofluorographic | 1 |
| IZX | Collimator, Manual, Radiographic | 1 |
| KPS | System, Tomography, Computed, Emission | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2021 | K203535 | Trinias Shimadzu Corporation Medical Systems, JP | OWB |
| Dec 15, 2008 | K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC Shimadzu Medical Systems | ITX |
| Jan 9, 2008 | K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 Shimadzu Medical Systems | ITX |
| Jan 9, 2008 | K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO Shimadzu Medical Systems | ITX |
| Jan 9, 2008 | K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO Shimadzu Medical Systems | ITX |
| Jul 27, 2006 | K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO Shimadzu Medical Systems | IYN |
| Jul 25, 2006 | K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO Shimadzu Medical Systems | IYN |
| Jul 14, 2006 | K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO Shimadzu Medical Systems | IYO |
| Oct 17, 2005 | K052500 | DAR-8000F Shimadzu Medical Systems | IZI |
| Sep 2, 2005 | K052076 | DAR-8000I Shimadzu Medical Systems | IZI |
| Apr 1, 2005 | K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 Shimadzu Medical Systems | IYN |
| Feb 12, 2001 | K003515 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 Shimadzu Medical Systems | IYN |
| Feb 12, 2001 | K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 Shimadzu Medical Systems | IYN |
| Mar 23, 2000 | K994431 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES Shimadzu Medical Systems | JAK |
| Apr 21, 1999 | K984156 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION Shimadzu Medical Systems | JAK |
| May 20, 1998 | K980837 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS Shimadzu Medical Systems | JAK |
| Mar 4, 1998 | K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| Oct 8, 1997 | K973329 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX Shimadzu Medical Systems | JAK |
| Oct 8, 1997 | K973327 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH Shimadzu Medical Systems | JAK |
| Aug 4, 1997 | K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| Dec 18, 1996 | K963888 | C-ARM TABLE IVS-100 Shimadzu Medical Systems | JAA |
| Nov 8, 1996 | K963617 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 Shimadzu Medical Systems | JAA |
| Feb 13, 1996 | K953634 | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| Feb 9, 1996 | K955255 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX Shimadzu Medical Systems | JAK |
| Jan 26, 1996 | K955254 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC Shimadzu Medical Systems | JAK |
| Jan 26, 1996 | K955253 | SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH Shimadzu Medical Systems | JAK |
| Dec 11, 1995 | K955395 | DAR-2400-15B/30B Shimadzu Medical Systems | IZI |
| May 11, 1995 | K951315 | CATHETERIZATION TABLE KS-60 Shimadzu Medical Systems | IZZ |
| May 11, 1995 | K936236 | SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES Shimadzu Medical Systems | JAA |
| Mar 21, 1995 | K945453 | UD 150L-R II Shimadzu Medical Systems | IZO |
| Mar 21, 1995 | K945452 | UD 150L-F Shimadzu Medical Systems | IZO |
| Feb 3, 1995 | K943545 | CEILING SUSPENDED C-ARM SUPPORT MH-100 Shimadzu Medical Systems | IZI |
| Feb 2, 1995 | K942669 | SMT-50CX/H Shimadzu Medical Systems | LNH |
| Nov 14, 1994 | K931021 | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. Shimadzu Medical Systems | IYO |
| Feb 18, 1994 | K932244 | SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems | LNH |
| Mar 16, 1993 | K923984 | SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems | LNH |
| Jan 15, 1993 | K925107 | SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems | LNH |
| Dec 7, 1992 | K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES Shimadzu Medical Systems | IYB |
| Dec 3, 1992 | K925169 | SHIMADZU RADIOGRAPJHIC STAND BR-100 Shimadzu Medical Systems | KPX |
| Nov 27, 1992 | K925175 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 Shimadzu Medical Systems | IXR |
| Nov 27, 1992 | K925174 | SHIMADZU RADIOGRAPHIC TABLE BK-100 Shimadzu Medical Systems | IZZ |
| Oct 5, 1992 | K923454 | SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES Shimadzu Medical Systems | JAA |
| Oct 5, 1992 | K923453 | SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES Shimadzu Medical Systems | JAA |
| Jun 16, 1992 | K922012 | SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES Shimadzu Medical Systems | JAA |
| Jun 10, 1992 | K922013 | SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES Shimadzu Medical Systems | JAA |
| Jun 10, 1992 | K922011 | SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES Shimadzu Medical Systems | JAA |
| May 29, 1992 | K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG Shimadzu Medical Systems | ITY |
| May 29, 1992 | K920726 | UROLOGICAL X-RAY TABLE HS-10A Shimadzu Medical Systems | IXR |
| May 28, 1992 | K921432 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF Shimadzu Medical Systems | JAK |
| May 28, 1992 | K920728 | X-RAY DIAGNOSTIC TABLE YSF-100 Shimadzu Medical Systems | IXR |
Newest 50 of 91.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2026 | Shimadzu Medical Systems 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 Rad Open, Classified |
OWB | K062360 K123508 +4 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Open, Classified |
JAA | K190373 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY TV SYSTEM SONIALVISION G4 Open, Classified |
JAA | K142341 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Open, Classified |
JAA | K191877 |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Shimadzu Trinias
Generator Model: D150GC-40 Open, Classified |
OWB | K123508 |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Bransist safire
Generator Model D150GC-40 Open, Classified |
IZI | K062360 |
| Nov 18, 2020 | Shimadzu Medical Systems 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 Open, Classified |
IZI | K943545 |
| Nov 18, 2020 | Shimadzu Medical Systems 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, Open, Classified |
OWB | K123508 |
| Nov 18, 2020 | Shimadzu Medical Systems 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 i Open, Classified |
IZI | K062360 |
| Nov 9, 2020 | Shimadzu Medical Systems 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 radiogra Open, Classified |
IZL | K080701 |
| Nov 4, 2019 | Shimadzu Medical Systems 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, Completed |
OWB | K123508 |
| Jan 12, 2018 | Shimadzu Medical Systems 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 an Terminated |
IZI | K052500 |
| Nov 20, 2016 | Shimadzu Medical Systems 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. Terminated |
IZO | None listed |
| Nov 20, 2016 | Shimadzu Medical Systems Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 Terminated |
JAA | K142341 |
| Apr 28, 2016 | Shimadzu Medical Systems 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 fol Terminated |
IXR | None listed |
| Nov 10, 2015 | Shimadzu Medical Systems 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 facil Terminated |
IZL | K080701 |
| Sep 30, 2015 | Shimadzu Medical Systems Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. Terminated |
JAA | K963888 |
| May 8, 2014 | Shimadzu Medical Systems 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. Terminated |
IZI | K052500 |
| Mar 7, 2014 | Shimadzu Medical Systems 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 outpatient Terminated |
IZL | K001517 |
| Jun 3, 2013 | Shimadzu Medical Systems 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 Terminated |
IZL | K080701 |
| Nov 8, 2012 | Shimadzu Medical Systems 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. Terminated |
IZL | K080701 |
| Nov 8, 2012 | Shimadzu Medical Systems 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. Terminated |
IZL | K090268 |
| Nov 8, 2012 | Shimadzu Medical Systems 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 Terminated |
IZL | K041763 |
| Nov 8, 2012 | Shimadzu Medical Systems 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 de Terminated |
IZL | K001517 |
| Nov 8, 2012 | Shimadzu Medical Systems 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 b Terminated |
IZX | K101036 |
| Nov 8, 2012 | Shimadzu Medical Systems 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 Terminated |
IZW | K090578 |