Company ยท US
Shimadzu Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2026. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 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 |
| IZW | Collimator, Automatic, Radiographic | 2 |
| LLZ | System, Image Processing, Radiological | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 |
| JOP | Transducer, Ultrasonic | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2026 | K252099 | Trinias Shimadzu Corporation, JP | OWB |
| Mar 28, 2024 | K233719 | FDR Visionary Suite Shimadzu Corporation, JP | KPR |
| Feb 23, 2024 | K233722 | RADspeed Pro Shimadzu Corporation, JP | KPR |
| Aug 5, 2019 | K191877 | FLUOROspeed Shimadzu Corporation, JP | JAA |
| Mar 15, 2019 | K190373 | SonialVision G4 Shimadzu Corporation, JP | JAA |
| Mar 30, 2018 | K173517 | RADspeed fit Shimadzu Corporation, JP | KPR |
| Jul 15, 2016 | K152294 | FDR Visionary Suite Shimadzu Corporation, JP | KPR |
| Jun 20, 2016 | K152244 | RADspeed Pro Shimadzu Corporation, JP | KPR |
| Mar 6, 2015 | K142341 | X-RAY TV SYSTEM SONIALVISION G4 Shimadzu Corp., JP | JAA |
| Mar 28, 2014 | K131075 | X-RAY TV SYSTEM SONIAL VISION G4 Shimadzu Corp. | JAA |
| Feb 26, 2014 | K123508 | TRINIAS Shimadzu Corporation, JP | OWB |
| Sep 20, 2010 | K101039 | SHIMADZU COLLIMATOR R-300 Shimadzu Corp. | IZW |
| Aug 26, 2010 | K101036 | SHIMADZU COLLIMATOR R-20J Shimadzu Corp. | IZX |
| Nov 6, 2009 | K090578 | SHIMADZU COLLIMATOR R-30H Shimadzu Corp. | IZW |
| Jun 30, 2009 | K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION Shimadzu Corp. | IZL |
| May 14, 2008 | K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp. | IZL |
| Aug 31, 2007 | K072006 | DAR-9400F Shimadzu Corp. | IZI |
| Jul 5, 2007 | K071717 | GE OEC ALTITUDE Shimadzu Corp., JP | IZI |
| Oct 5, 2006 | K062360 | BRANSIST SAFIRE Shimadzu Corp. | IZI |
| Jun 1, 2005 | K050925 | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE Shimadzu Corp. | MQB |
| Feb 17, 2005 | K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 Shimadzu Corp. | OXO |
| Dec 3, 2004 | K042840 | SHIMADZU COLLIMATOR R-20J Shimadzu Corp. | IZX |
| Jul 13, 2004 | K041763 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES Shimadzu Corp. | IZL |
| May 17, 2004 | K040870 | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS Shimadzu Corp. | JAA |
| Feb 20, 2004 | K032443 | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE Shimadzu Corp. | IZI |
| Dec 9, 2003 | K033184 | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 Shimadzu Corp. | IZI |
| Aug 21, 2003 | K031771 | SHIMADZU COLLIMATOR R-30H Shimadzu Corp. | IZX |
| Oct 18, 2001 | K012424 | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM Shimadzu Corp. | JAA |
| Jul 3, 2001 | K011141 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC Shimadzu Corp. | JAK |
| Jun 27, 2000 | K001517 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES Shimadzu Corp. | IZL |
| Jun 8, 1999 | K991553 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION Shimadzu Corp. | JAK |
| Apr 16, 1999 | K990715 | SHIMADZU CEILING TUBE SUPPORT CH-30GH Shimadzu Corp. | KPR |
| Oct 5, 1998 | K982583 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL Shimadzu Corp. | JAK |
| Oct 8, 1997 | K973342 | DAR-3000B Shimadzu Corp. | IZI |
| Dec 22, 1995 | K955036 | MOBILE X-RAY SYSTEM Shimadzu Corp., JP | IZL |
| Jul 12, 1995 | K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G Shimadzu Corp., JP | IZO |
| Feb 7, 1995 | K945389 | IVR MASTER Shimadzu Corp. | LLZ |
| Jan 30, 1995 | K945388 | DFS-700 Shimadzu Corp. | LLZ |
| Oct 13, 1994 | K942731 | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR Shimadzu Corp. | IZO |
| Jul 29, 1994 | K942792 | BUCKY STAND BR-10M Shimadzu Corp. | KPR |
| Jul 5, 1994 | K935487 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF Shimadzu Corp. | JAK |
| Feb 7, 1994 | K933472 | SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES Shimadzu Corp., JP | JAA |
| Dec 13, 1993 | K934967 | SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR Shimadzu Corp. | IZO |
| Nov 24, 1993 | K934005 | SHIMADZU CEILING TUBE SUPPORT CH-30GX Shimadzu Corp. | KPR |
| Nov 24, 1993 | K933473 | CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM Shimadzu Corp., JP | JAA |
| Nov 24, 1993 | K933471 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G Shimadzu Corp., JP | IZO |
| Aug 21, 1990 | K897073 | ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 Shimadzu Corp. | ITX |
| Aug 21, 1990 | K896644 | ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 Shimadzu Corp. | ITX |
| Aug 9, 1990 | K896999 | SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT Shimadzu Corp. | IYO |
| Nov 13, 1989 | K895394 | MOBILE X-RAY TELEVISION UNIT WHA-10A/B Shimadzu Corp., JP | JAA |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||