Canon Medical Systems Corporation - FDA 510(k) Cleared Devices
95
Total
95
Cleared
0
Denied
95 devices
Cleared
Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Radiology
202d
Cleared
Mar 31, 2023
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
Radiology
183d
Cleared
Mar 07, 2023
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Radiology
84d
Cleared
Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Radiology
165d
Cleared
Jan 09, 2023
Vitrea Software Package, VSTP-002A
Radiology
69d
Cleared
Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
Radiology
28d
Cleared
Sep 27, 2022
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
Radiology
232d
Cleared
Sep 12, 2022
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Radiology
161d
Cleared
Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Radiology
23d
Cleared
Jun 16, 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea...
Radiology
227d
Cleared
Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Radiology
74d
Cleared
Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
Radiology
57d
Cleared
Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Radiology
187d
Cleared
Mar 03, 2022
MR Elastography
Radiology
57d
Cleared
Jan 24, 2022
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
Radiology
181d
Cleared
Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit...
Radiology
58d
Cleared
Sep 10, 2021
Aquilion Exceed LB
Radiology
88d
Cleared
Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Radiology
34d
Cleared
Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
Radiology
56d
Cleared
May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Radiology
40d
Cleared
Apr 23, 2021
Cartesion Prime (PCD-1000A/3) V10.8
Radiology
164d
Cleared
Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Radiology
17d
Cleared
Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
Radiology
55d
Cleared
Mar 24, 2021
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Radiology
142d
Cleared
Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
Radiology
48d
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