Shimadzu Precision Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K940294SHIMADZU MOBILE X-RAY SYSTEMSMarch 16, 1994
K890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENTSeptember 6, 1989
K884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200April 20, 1989
K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150BMarch 15, 1989
K875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSIONNovember 16, 1988
K882311SHIMADZU LATERAL C-ARM MH-31September 14, 1988
K881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TCSeptember 2, 1988
K881795SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150KJuly 1, 1988
K874910SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200July 1, 1988
K875370SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TXMay 18, 1988
K874946SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60March 3, 1988
K874767SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11February 25, 1988
K875377SHIMADZU MAMMOGRAPHIC STAND MR-30February 12, 1988
K875375SHIMADZU LATERAL C-ARM MH-30February 12, 1988
K875379SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100AFebruary 12, 1988
K875373C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20February 12, 1988
K875380SHIMADZU CATHETERIZATION C-ARM STAND MH-10February 12, 1988
K875376SHIMADZU CATHETERIZATION C-ARM STAND MH-50BFebruary 12, 1988
K875374SHIMADZU CEILING-SUSPENDED C-ARM CH-50February 12, 1988
K875372SHIMADZU CATHETERIZATION C-ARM STAND ER-200February 12, 1988