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Canon Medical Systems Corporation FDA Approvals
0 new drug approvals and 57 device clearances on file. Matched by name to CAJPY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Aquilion ONE (TSX-308A/TSX-306A) V2.0510(k)May 20, 2026Radiology |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR510(k)Mar 27, 2026Radiology |
| Aquilion ServeSP (TSX-307B) V2.0510(k)Mar 13, 2026Radiology |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)510(k)Mar 10, 2026Radiology |
| Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System510(k)Jan 20, 2026Radiology |
| Cartesion Prime (PCD-1000A/3) V10.21510(k)Dec 1, 2025Radiology |
| Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System510(k)Oct 31, 2025Radiology |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging510(k)Oct 10, 2025Radiology |
| Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP510(k)Sep 26, 2025Radiology |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR510(k)Jul 22, 2025Radiology |
| CT Scanner TSX-501R/1 V11.1510(k)Jun 20, 2025Radiology |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5510(k)May 13, 2025Radiology |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program510(k)Apr 30, 2025Radiology |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR510(k)Jan 7, 2025Radiology |
| Aquilion ONE (TSX-308A/3) V1.5510(k)Dec 23, 2024Radiology |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)510(k)Sep 12, 2024Radiology |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5510(k)Aug 30, 2024Radiology |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR510(k)Aug 20, 2024Radiology |
| Vitrea Software Package, VSTP-002A V2.0510(k)Jul 17, 2024Radiology |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR510(k)Apr 12, 2024Radiology |
| Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System510(k)Apr 2, 2024Radiology |
| Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System510(k)Jan 24, 2024Radiology |
| Aquilion Serve SP (TSX-307B/1) V1.3510(k)Dec 6, 2023Radiology |
| Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System510(k)Nov 21, 2023Radiology |
| Aquilion Serve (TSX-307A/1) V1.3510(k)Sep 19, 2023Radiology |
| Cartesion Prime (PCD-1000A/3) V10.15510(k)Sep 12, 2023Radiology |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5510(k)Sep 12, 2023Radiology |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR510(k)Aug 30, 2023Radiology |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0510(k)Mar 31, 2023Radiology |
| Aquilion Precision (TSX-304A/4) V10.14 with AiCE510(k)Mar 7, 2023Radiology |
| Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i510(k)Mar 3, 2023Radiology |
| Vitrea Software Package, VSTP-002A510(k)Jan 9, 2023Radiology |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR510(k)Oct 25, 2022Radiology |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3510(k)Sep 27, 2022Radiology |
| Aquilion Precision (TSX-304A/4) V10.10 with AiCE510(k)Sep 12, 2022Radiology |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR510(k)Aug 31, 2022Radiology |
| Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A510(k)Jun 16, 2022Radiology |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR510(k)Apr 8, 2022Radiology |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR510(k)Apr 5, 2022Radiology |
| Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5510(k)Mar 22, 2022Radiology |
| MR Elastography; MZEK-001A510(k)Mar 3, 2022Radiology |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5510(k)Jan 24, 2022Radiology |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR510(k)Dec 1, 2021Radiology |
| Aquilion Exceed LB510(k)Sep 10, 2021Radiology |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR510(k)Aug 4, 2021Radiology |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR510(k)Jul 22, 2021Radiology |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR510(k)May 17, 2021Radiology |
| Cartesion Prime (PCD-1000A/3) V10.8510(k)Apr 23, 2021Radiology |
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2510(k)Apr 12, 2021Radiology |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR510(k)Apr 1, 2021Radiology |
| Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System510(k)Mar 24, 2021Radiology |
| Vantage Elan 1.5T, MRT-2020, V6.0510(k)Mar 10, 2021Radiology |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR510(k)Mar 4, 2021Radiology |
| Vitrea Software Package, VSTP-001A510(k)Feb 16, 2021Radiology |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR510(k)Feb 2, 2021Radiology |
| Vantage Orian 1.5T, MRT-1550, V6.0510(k)Jan 15, 2021Radiology |
| Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i510(k)Jan 12, 2021Radiology |