Canon Medical Systems Corporation - FDA 510(k) Cleared Devices
95
Total
95
Cleared
0
Denied
95 devices
Cleared
Jul 05, 2019
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
Radiology
262d
Cleared
Jun 26, 2019
Vantage Titan 3T, MRT-3010, V2.5
Radiology
58d
Cleared
Jun 12, 2019
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Radiology
222d
Cleared
Jun 05, 2019
Low Dose Lung Screening Option
Radiology
96d
Cleared
Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
Radiology
78d
Cleared
Dec 14, 2018
Vitrea Software Package, VSTP-001A
Radiology
84d
Cleared
Nov 26, 2018
Vitrea Software Package, VSTP-001A
Radiology
26d
Cleared
Nov 16, 2018
Celesteion, PCA-9000A/3, V6.5
Radiology
147d
Cleared
Nov 02, 2018
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
Radiology
57d
Cleared
Nov 02, 2018
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Radiology
43d
Cleared
Oct 31, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Radiology
35d
Cleared
Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
Radiology
57d
Cleared
Oct 17, 2018
Alphenix, INFX-8000H/B, V8.0
Radiology
30d
Cleared
Sep 28, 2018
Alphenix, INFX-8000F/B, V8.0
Radiology
24d
Cleared
Sep 10, 2018
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
Radiology
103d
Cleared
Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
Radiology
56d
Cleared
Aug 02, 2018
Alphenix, INFX-8000C/B, V8.0
Radiology
27d
Cleared
Jul 25, 2018
Alphenix, INFX-8000V/B, V8.0
Radiology
30d
Cleared
Jul 19, 2018
Ultimax-i, DREX-UI80 (V1.60)
Radiology
9d
Cleared
Mar 30, 2018
Vitrea Software Package
Radiology
53d
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