Shimadzu Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K142341X-RAY TV SYSTEM SONIALVISION G4March 6, 2015
K131075X-RAY TV SYSTEM SONIAL VISION G4March 28, 2014
K101039SHIMADZU COLLIMATOR R-300September 20, 2010
K101036SHIMADZU COLLIMATOR R-20JAugust 26, 2010
K090578SHIMADZU COLLIMATOR R-30HNovember 6, 2009
K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONJune 30, 2009
K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONMay 14, 2008
K072006DAR-9400FAugust 31, 2007
K071717GE OEC ALTITUDEJuly 5, 2007
K062360BRANSIST SAFIREOctober 5, 2006
K050925DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIREJune 1, 2005
K043379SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200February 17, 2005
K042840SHIMADZU COLLIMATOR R-20JDecember 3, 2004
K041763SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIESJuly 13, 2004
K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HSMay 17, 2004
K032443DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIREFebruary 20, 2004
K033184LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400December 9, 2003
K031771SHIMADZU COLLIMATOR R-30HAugust 21, 2003
K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LMOctober 18, 2001
K011141SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TCJuly 3, 2001