Canon Medical Systems Corporation - FDA 510(k) Cleared Devices
95
Total
95
Cleared
0
Denied
95 devices
Cleared
Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Radiology
112d
Cleared
Feb 16, 2021
Vitrea Software Package, VSTP-001A
Radiology
98d
Cleared
Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Radiology
60d
Cleared
Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
Radiology
116d
Cleared
Jan 12, 2021
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Radiology
194d
Cleared
Dec 18, 2020
Alphenix, INFX-8000V/B, /S, V9.1
Radiology
14d
Cleared
Dec 10, 2020
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Radiology
65d
Cleared
Dec 02, 2020
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
Radiology
56d
Cleared
Oct 16, 2020
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio...
Radiology
28d
Cleared
Oct 15, 2020
Cartesion Prime, PCD-1000A, V10.7
Radiology
58d
Cleared
Oct 15, 2020
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
Radiology
57d
Cleared
Oct 08, 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
Radiology
85d
Cleared
Sep 22, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
Radiology
47d
Cleared
Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
Radiology
250d
Cleared
Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
Radiology
217d
Cleared
Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Radiology
172d
Cleared
Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
Radiology
172d
Cleared
Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Radiology
142d
Cleared
Feb 14, 2020
Vitrea Software Package
Radiology
121d
Cleared
Feb 13, 2020
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Radiology
134d
Cleared
Sep 18, 2019
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
Radiology
89d
Cleared
Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
Radiology
24d
Cleared
Aug 13, 2019
Cartesion Prime
Radiology
60d
Cleared
Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
Radiology
32d
Cleared
Jul 19, 2019
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Radiology
46d
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