Canon Medical Systems Corporation
FDA 510(k) & PMA Approved Devices — 97 products
Total Devices97
Categories8
Latest FDA decision2026-05-20
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | JAK | 2026-05-20 | View |
| 510(k) | K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2026-03-27 | View |
| 510(k) | K260078 | Aquilion ServeSP (TSX-307B) V2.0 | JAK | 2026-03-13 | View |
| 510(k) | K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | OWB | 2026-03-10 | View |
| 510(k) | K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | IYN | 2026-01-20 | View |
| 510(k) | K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | KPS | 2025-12-01 | View |
| 510(k) | K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | IYN | 2025-10-31 | View |
| 510(k) | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | OWB | 2025-10-10 | View |
| 510(k) | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | JAK | 2025-09-26 | View |
| 510(k) | K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2025-07-22 | View |
| 510(k) | K243398 | CT Scanner TSX-501R/1 V11.1 | JAK | 2025-06-20 | View |
| 510(k) | K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | IYN | 2025-05-13 | View |
| 510(k) | K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | QIH | 2025-04-30 | View |
| 510(k) | K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2025-01-07 | View |
| 510(k) | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | JAK | 2024-12-23 | View |
| 510(k) | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | IYN | 2024-09-12 | View |
| 510(k) | K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | OWB | 2024-08-30 | View |
| 510(k) | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2024-08-20 | View |
| 510(k) | K240705 | Vitrea Software Package, VSTP-002A V2.0 | LLZ | 2024-07-17 | View |
| 510(k) | K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2024-04-12 | View |
No matching devices.
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