Shimadzu Corporation - FDA 510(k) Cleared Devices
Recent clearances: Trinias, FDR Visionary Suite, RADspeed Pro
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shimadzu Corporation Radiology ✕
9 devices
Cleared
Mar 24, 2026
Trinias
Radiology
264d
Cleared
Mar 28, 2024
FDR Visionary Suite
Radiology
128d
Cleared
Feb 23, 2024
RADspeed Pro
Radiology
94d
Cleared
Aug 05, 2019
FLUOROspeed
Radiology
21d
Cleared
Mar 15, 2019
SonialVision G4
Radiology
24d
Cleared
Mar 30, 2018
RADspeed fit
Radiology
136d
Cleared
Jul 15, 2016
FDR Visionary Suite
Radiology
337d
Cleared
Jun 20, 2016
RADspeed Pro
Radiology
315d
Cleared
Feb 26, 2014
TRINIAS
Radiology
470d