Canon Medical Systems Corporation - FDA 510(k) Cleared Devices
Recent clearances: Aquilion ONE (TSX-308A/TSX-306A) V2.0, Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR, Aquilion ServeSP (TSX-307B) V2.0
97
Total
97
Cleared
0
Denied
FDA 510(k) Regulatory Record - Canon Medical Systems Corporation Radiology ✕
97 devices
Cleared
May 20, 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Radiology
183d
Cleared
Mar 27, 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
Radiology
129d
Cleared
Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
Radiology
60d
Cleared
Mar 10, 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Radiology
113d
Cleared
Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Radiology
63d
Cleared
Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
Radiology
213d
Cleared
Oct 31, 2025
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Radiology
121d
Cleared
Oct 10, 2025
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Radiology
136d
Cleared
Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
Radiology
120d
Cleared
Jul 22, 2025
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
Radiology
118d
Cleared
Jun 20, 2025
CT Scanner TSX-501R/1 V11.1
Radiology
232d
Cleared
May 13, 2025
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
Radiology
238d
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