Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Canon Medical Systems Corporation · Predicate Candidate Screening
97 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
213 days90th percentile
97clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 | 183 | 0 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Recons | Canon Medical Systems Corporation | 2026-03-27 | 129 | 0 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 | 60 | 0 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imag | Canon Medical Systems Corporation | 2026-03-10 | 113 | 0 |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasoun | Canon Medical Systems Corporation | 2026-01-20 | 63 | 0 |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | 2025-12-01 | 213 | 0 |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnost | Canon Medical Systems Corporation | 2025-10-31 | 121 | 0 |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imag | Canon Medical Systems Corporation | 2025-10-10 | 136 | 0 |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8 | Canon Medical Systems Corporation | 2025-09-26 | 120 | 0 |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Recons | Canon Medical Systems Corporation | 2025-07-22 | 118 | 0 |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025-06-20 | 232 | 0 |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software | Canon Medical Systems Corporation | 2025-05-13 | 238 | 0 |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Prog | Canon Medical Systems Corporation | 2025-04-30 | 84 | 0 |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction P | Canon Medical Systems Corporation | 2025-01-07 | 75 | 1 |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024-12-23 | 132 | 0 |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software | Canon Medical Systems Corporation | 2024-09-12 | 101 | 0 |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | 2024-08-30 | 338 | 2 |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction P | Canon Medical Systems Corporation | 2024-08-20 | 84 | 0 |
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation | 2024-07-17 | 125 | 0 |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconst | Canon Medical Systems Corporation | 2024-04-12 | 74 | 0 |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction Syst | Canon Medical Systems Corporation | 2024-04-02 | 201 | 0 |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnost | Canon Medical Systems Corporation | 2024-01-24 | 118 | 0 |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | 2023-12-06 | 68 | 0 |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound | Canon Medical Systems Corporation | 2023-11-21 | 60 | 0 |
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | 2023-09-19 | 139 | 0 |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | 2023-09-12 | 89 | 1 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023-09-12 | 22 | 0 |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Pr | Canon Medical Systems Corporation | 2023-08-30 | 202 | 2 |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software | Canon Medical Systems Corporation | 2023-03-31 | 183 | 0 |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | 2023-03-07 | 84 | 0 |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | 2023-03-03 | 165 | 0 |
| K223336 | Vitrea Software Package, VSTP-002A | Canon Medical Systems Corporation | 2023-01-09 | 69 | 0 |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconst | Canon Medical Systems Corporation | 2022-10-25 | 28 | 2 |
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | Canon Medical Systems Corporation | 2022-09-27 | 232 | 0 |
| K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | 2022-09-12 | 161 | 0 |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Pr | Canon Medical Systems Corporation | 2022-08-31 | 23 | 0 |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging Syste | Canon Medical Systems Corporation | 2022-06-16 | 227 | 0 |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Pr | Canon Medical Systems Corporation | 2022-04-08 | 74 | 0 |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconst | Canon Medical Systems Corporation | 2022-04-05 | 57 | 0 |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound S | Canon Medical Systems Corporation | 2022-03-22 | 187 | 1 |
| K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | 2022-03-03 | 57 | 0 |
| K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software | Canon Medical Systems Corporation | 2022-01-24 | 181 | 1 |
| K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstructio | Canon Medical Systems Corporation | 2021-12-01 | 58 | 0 |
| K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | 2021-09-10 | 88 | 0 |
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Pr | Canon Medical Systems Corporation | 2021-08-04 | 34 | 0 |
| K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction | Canon Medical Systems Corporation | 2021-07-22 | 56 | 0 |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Pr | Canon Medical Systems Corporation | 2021-05-17 | 40 | 0 |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | 2021-04-23 | 164 | 0 |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | 2021-04-12 | 17 | 4 |
| K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction | Canon Medical Systems Corporation | 2021-04-01 | 55 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda