Shimadzu Corp.
Medical device manufacturer in Kyoto, JP.
58510(k) clearances
0PMA approvals
0recalls
Device types
- JAA System, X-Ray, Fluoroscopic… 9
- KPR System, X-Ray, Stationary 8
- IYO System, Imaging, Pulsed Echo, Ultrasonic 6
- IZI System, X-Ray, Angiographic 6
- IZL System, X-Ray, Mobile 5
- IZO Generator, High-Voltage, X-Ray, Diagnostic 4
- JAK System, X-Ray, Tomography, Computed 4
- ITX Transducer, Ultrasonic, Diagnostic 3
- IZX Collimator, Manual, Radiographic 3
- LLZ System, Image Processing, Radiological 2
- IZW Collimator, Automatic, Radiographic 2
- OWB Interventional Fluoroscopic X-Ray System 2
- JOP Transducer, Ultrasonic 1
- OXO Image-Intensified Fluoroscopic X-Ray… 1
- MQB Solid State X-Ray Imager (Flat… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252099 | TriniasOWB · Abbreviated | 03/24/2026SE |
| K233719 | FDR Visionary SuiteKPR · Traditional | 03/28/2024SE |
| K233722 | RADspeed ProKPR · Traditional | 02/23/2024SE |
| K191877 | FLUOROspeedJAA · Special | 08/05/2019SE |
| K190373 | SonialVision G4JAA · Special | 03/15/2019SE |
| K173517 | RADspeed fitKPR · Traditional | 03/30/2018SE |
| K152294 | FDR Visionary SuiteKPR · Traditional | 07/15/2016SE |
| K152244 | RADspeed ProKPR · Traditional | 06/20/2016SE |
| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
| K131075 | X-Ray TV System Sonial Vision G4JAA · Abbreviated | 03/28/2014SE |
| K123508 | TriniasOWB · Abbreviated | 02/26/2014SE |
| K101039 | Shimadzu Collimator R-300IZW · Abbreviated | 09/20/2010SE |
| K101036 | Shimadzu Collimator R-20JIZX · Abbreviated | 08/26/2010SE |
| K090578 | Shimadzu Collimator R-30HIZW · Abbreviated | 11/06/2009SE |
| K090268 | Shimadzu Mobile X-Ray System Mobile Art EvolutionIZL · Abbreviated | 06/30/2009SE |
| K080701 | Shimadzu Mobile X-Ray System Mobiledart EvolutionIZL · Abbreviated | 05/14/2008SE |
| K072006 | DAR-9400FIZI · Abbreviated | 08/31/2007SE |
| K071717 | GE Oec AltitudeIZI · Traditional | 07/05/2007SE |
| K062360 | Bransist SafireIZI · Abbreviated | 10/05/2006SE |
| K050925 | Digital Radiography System Radspeed SafireMQB · Abbreviated | 06/01/2005SE |
| K043379 | Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model WHA-200OXO · Abbreviated | 02/17/2005SE |
| K042840 | Shimadzu Collimator R-20JIZX · Abbreviated | 12/03/2004SE |
| K041763 | Shimadzu Mobile X-Ray System MUX-100D SeriesIZL · Traditional | 07/13/2004SE |
| K040870 | Shimadzu Image Amplifier, Model IA-16L/HSJAA · Traditional | 05/17/2004SE |
| K032443 | Digital Angiography System Digitex SafireIZI · Abbreviated | 02/20/2004SE |
| K033184 | Lateral Angiographic C-Arm Support MH-400IZI · Traditional | 12/09/2003SE |
| K031771 | Shimadzu Collimator R-30HIZX · Abbreviated | 08/21/2003SE |
| K012424 | Shimadzu Image Amplifier Model # IA-16LMJAA · Traditional | 10/18/2001SE |
| K011141 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TCJAK · Traditional | 07/03/2001SE |
| K001517 | Shimadzu Mobile X-Ray System MUX-100 SeriesIZL · Abbreviated | 06/27/2000SE |
| K991553 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TS W/Fluoro OptionJAK · Abbreviated | 06/08/1999SE |
| K990715 | Shimadzu Ceiling Tube Support CH-30GHKPR · Abbreviated | 04/16/1999SE |
| K982583 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TXLJAK · Traditional | 10/05/1998SE |
| K973342 | DAR-3000BIZI · Traditional | 10/08/1997SE |
| K955036 | Mobile X-Ray SystemIZL · Traditional | 12/22/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | 07/12/1995SE |
| K945389 | Ivr MasterLLZ · Traditional | 02/07/1995SE |
| K945388 | DFS-700LLZ · Traditional | 01/30/1995SE |
| K942731 | Shimazu Whole Body X-Ray CT Scanner SCT-4800TF/GRIZO · Traditional | 10/13/1994SE |
| K942792 | Bucky Stand BR-10MKPR · Traditional | 07/29/1994SE |
| K935487 | Shimadzu Whole Body X-Ray CT Scanner SCT-4800TFJAK · Traditional | 07/05/1994SE |
| K933472 | Shimadzu Digital Substraction Syst DAR-2400 SeriesJAA · Traditional | 02/07/1994SE |
| K934967 | Shimadzu UD150L-R X-Ray High Voltage GeneratorIZO · Traditional | 12/13/1993SE |
| K934005 | Shimadzu Ceiling Tube Support CH-30GXKPR · Traditional | 11/24/1993SE |
| K933473 | Catheterization C-Arm Support MH-51BM/MH-51CMJAA · Traditional | 11/24/1993SE |
| K933471 | Shimadzu X-Ray High Voltage Generator AUD150GIZO · Traditional | 11/24/1993SE |
| K897073 | Additional Transducers for Use W/Sdl 300ITX · Traditional | 08/21/1990SE |
| K896644 | Additional Transducers for Use with Sdu 500ITX · Traditional | 08/21/1990SE |
| K896999 | SDL 310 Diagnostic Ultrasound InstrumentIYO · Traditional | 08/09/1990SE |
| K895394 | Mobile X-Ray Television Unit WHA-10A/BJAA · Traditional | 11/13/1989SE |
| K875187 | SDU-500 Diagnostic Ultrasound InstrumentIYO · Traditional | 12/12/1988SE |
| K873674 | SDU-700 Phased Array Sector and Linear ScannerJOP · Traditional | 10/07/1988SE |
| K854337 | SDL-300ITX · Traditional | 06/20/1986SE |
| K850834 | SDL-32 Electronic Linear ScannerIYO · Traditional | 10/31/1985SE |
| K834280 | SDL-30IYO · Traditional | 04/25/1984SE |
| K840611 | DSL-150IYO · Traditional | 04/20/1984SE |
| K837314 | SDL-10 Diagnostic Ultrasound · Traditional | 04/29/1983SE |
| K791040 | Sector Scanner, SDU-100, ComputerizedIYO · Traditional | 10/04/1979SE |