Medical Device Manufacturer · US , Mchenry , IL

Shimadzu Corp.

49 submissions · 49 cleared · Since 1979
49
Total
49
Cleared
0
Denied

Shimadzu Corp. — FDA 510(k) Submissions

Shimadzu Corp. has submitted 49 FDA 510(k) premarket notifications since 1979, of which 49 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Fluoroscopic, Image-intensified, System, Imaging, Pulsed Echo, Ultrasonic, System, X-ray, Angiographic, System, X-ray, Mobile, Generator, High-voltage, X-ray, Diagnostic . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
X-RAY TV SYSTEM SONIALVISION G4
K142341 · JAA System, X-ray,... · Radiology
Mar 2015 197d
X-RAY TV SYSTEM SONIAL VISION G4
K131075 · JAA System, X-ray,... · Radiology
Mar 2014 345d
SHIMADZU COLLIMATOR R-300
K101039 · IZW Collimator, Automatic,... · Radiology
Sep 2010 159d
SHIMADZU COLLIMATOR R-20J
K101036 · IZX Collimator, Manual,... · Radiology
Aug 2010 134d
SHIMADZU COLLIMATOR R-30H
K090578 · IZW Collimator, Automatic,... · Radiology
Nov 2009 248d
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K090268 · IZL System, X-ray, Mobile · Radiology
Jun 2009 147d
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · IZL System, X-ray, Mobile · Radiology
May 2008 64d
DAR-9400F
K072006 · IZI System, X-ray, Angiographic · Radiology
Aug 2007 39d
GE OEC ALTITUDE
K071717 · IZI System, X-ray, Angiographic · Radiology
Jul 2007 13d
BRANSIST SAFIRE
K062360 · IZI System, X-ray, Angiographic · Radiology
Oct 2006 52d
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925 · MQB Solid State X-ray Imager... · Radiology
Jun 2005 49d
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379 · OXO Image-intensified... · Radiology
Feb 2005 71d
SHIMADZU COLLIMATOR R-20J
K042840 · IZX Collimator, Manual,... · Radiology
Dec 2004 50d
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · IZL System, X-ray, Mobile · Radiology
Jul 2004 13d
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K040870 · JAA System, X-ray,... · Radiology
May 2004 45d
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · IZI System, X-ray, Angiographic · Radiology
Feb 2004 196d
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184 · IZI System, X-ray, Angiographic · Radiology
Dec 2003 69d
SHIMADZU COLLIMATOR R-30H
K031771 · IZX Collimator, Manual,... · Radiology
Aug 2003 73d
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA System, X-ray,... · Radiology
Oct 2001 80d
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · JAK System, X-ray,... · Radiology
Jul 2001 81d
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · IZL System, X-ray, Mobile · Radiology
Jun 2000 42d
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
K991553 · JAK System, X-ray,... · Radiology
Jun 1999 36d
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K990715 · KPR System, X-ray, Stationary · Radiology
Apr 1999 43d
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K982583 · JAK System, X-ray,... · Radiology
Oct 1998 73d
DAR-3000B
K973342 · IZI System, X-ray, Angiographic · Radiology
Oct 1997 33d
Filters