| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) | Canon Medical Systems Corporation | 2026-03-27 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (K253597) | Canon Medical Systems Corporation | 2026-01-20 |
| Cartesion Prime (PCD-1000A/3) V10.21 (K251370) | Canon Medical Systems Corporation | 2025-12-01 |
| Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (K252074) | Canon Medical Systems Corporation | 2025-10-31 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (K251602) | Canon Medical Systems Corporation | 2025-10-10 |
| Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (K251645) | Canon Medical Systems Corporation | 2025-09-26 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K250901) | Canon Medical Systems Corporation | 2025-07-22 |
| CT Scanner TSX-501R/1 V11.1 (K243398) | Canon Medical Systems Corporation | 2025-06-20 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808) | Canon Medical Systems Corporation | 2025-05-13 |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) | Canon Medical Systems Corporation | 2025-04-30 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) | Canon Medical Systems Corporation | 2025-01-07 |
| Aquilion ONE (TSX-308A/3) V1.5 (K242403) | Canon Medical Systems Corporation | 2024-12-23 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) (K241582) | Canon Medical Systems Corporation | 2024-09-12 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (K233107) | Canon Medical Systems Corporation | 2024-08-30 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K241496) | Canon Medical Systems Corporation | 2024-08-20 |
| Vitrea Software Package, VSTP-002A V2.0 (K240705) | Canon Medical Systems Corporation | 2024-07-17 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238) | Canon Medical Systems Corporation | 2024-04-12 |
| Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (K232835) | Canon Medical Systems Corporation | 2024-04-02 |
| Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (K233195) | Canon Medical Systems Corporation | 2024-01-24 |
| Aquilion Serve SP (TSX-307B/1) V1.3 (K233334) | Canon Medical Systems Corporation | 2023-12-06 |
| Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System (K232988) | Canon Medical Systems Corporation | 2023-11-21 |
| Aquilion Serve (TSX-307A/1) V1.3 (K231281) | Canon Medical Systems Corporation | 2023-09-19 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) | Canon Medical Systems Corporation | 2023-09-12 |
| Cartesion Prime (PCD-1000A/3) V10.15 (K231748) | Canon Medical Systems Corporation | 2023-09-12 |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355) | Canon Medical Systems Corporation | 2023-08-30 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017) | Canon Medical Systems Corporation | 2023-03-31 |
| Aquilion Precision (TSX-304A/4) V10.14 with AiCE (K223726) | Canon Medical Systems Corporation | 2023-03-07 |
| Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819) | Canon Medical Systems Corporation | 2023-03-03 |
| Vitrea Software Package, VSTP-002A (K223336) | Canon Medical Systems Corporation | 2023-01-09 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K222968) | Canon Medical Systems Corporation | 2022-10-25 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342) | Canon Medical Systems Corporation | 2022-09-27 |
| Aquilion Precision (TSX-304A/4) V10.10 with AiCE (K220986) | Canon Medical Systems Corporation | 2022-09-12 |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K222387) | Canon Medical Systems Corporation | 2022-08-31 |
| Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (K213504) | Canon Medical Systems Corporation | 2022-06-16 |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192) | Canon Medical Systems Corporation | 2022-04-08 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335) | Canon Medical Systems Corporation | 2022-04-05 |
| Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 (K212960) | Canon Medical Systems Corporation | 2022-03-22 |
| MR Elastography; MZEK-001A (K220018) | Canon Medical Systems Corporation | 2022-03-03 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (K212333) | Canon Medical Systems Corporation | 2022-01-24 |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305) | Canon Medical Systems Corporation | 2021-12-01 |
| Aquilion Exceed LB (K211828) | Canon Medical Systems Corporation | 2021-09-10 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K212056) | Canon Medical Systems Corporation | 2021-08-04 |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633) | Canon Medical Systems Corporation | 2021-07-22 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K211037) | Canon Medical Systems Corporation | 2021-05-17 |
| Cartesion Prime (PCD-1000A/3) V10.8 (K203314) | Canon Medical Systems Corporation | 2021-04-23 |
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K210340) | Canon Medical Systems Corporation | 2021-04-01 |
| Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (K203225) | Canon Medical Systems Corporation | 2021-03-24 |
| Vantage Elan 1.5T, MRT-2020, V6.0 (K210164) | Canon Medical Systems Corporation | 2021-03-10 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323) | Canon Medical Systems Corporation | 2021-03-04 |
| Vitrea Software Package, VSTP-001A (K203312) | Canon Medical Systems Corporation | 2021-02-16 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553) | Canon Medical Systems Corporation | 2021-02-02 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K202767) | Canon Medical Systems Corporation | 2021-01-15 |
| Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836) | Canon Medical Systems Corporation | 2021-01-12 |
| Alphenix, INFX-8000V/B, /S, V9.1 (K203551) | Canon Medical Systems Corporation | 2020-12-18 |
| Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I (K203042) | Canon Medical Systems Corporation | 2020-12-10 |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K203053) | Canon Medical Systems Corporation | 2020-12-02 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System (K202737) | Canon Medical Systems Corporation | 2020-10-16 |
| Cartesion Prime, PCD-1000A, V10.7 (K202349) | Canon Medical Systems Corporation | 2020-10-15 |
| Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 (K202364) | Canon Medical Systems Corporation | 2020-10-15 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (K201972) | Canon Medical Systems Corporation | 2020-10-08 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K202210) | Canon Medical Systems Corporation | 2020-09-22 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097) | Canon Medical Systems Corporation | 2020-07-14 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K193021) | Canon Medical Systems Corporation | 2020-06-03 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574) | Canon Medical Systems Corporation | 2020-03-09 |
| Vantage Galan 3T, MRT-3020, V6.0 (K192506) | Canon Medical Systems Corporation | 2020-03-02 |
| Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (K192832) | Canon Medical Systems Corporation | 2020-02-21 |
| Vitrea Software Package (K192923) | Canon Medical Systems Corporation | 2020-02-14 |
| Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (K192828) | Canon Medical Systems Corporation | 2020-02-13 |
| Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663) | Canon Medical Systems Corporation | 2019-09-18 |
| Aquilion ONE (TSX-306A/3) V10.0 (K192188) | Canon Medical Systems Corporation | 2019-09-06 |
| Cartesion Prime (K191582) | Canon Medical Systems Corporation | 2019-08-13 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K191662) | Canon Medical Systems Corporation | 2019-07-23 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (K191467) | Canon Medical Systems Corporation | 2019-07-19 |
| Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (K182901) | Canon Medical Systems Corporation | 2019-07-05 |
| Vantage Titan 3T, MRT-3010, V2.5 (K191128) | Canon Medical Systems Corporation | 2019-06-26 |
| Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046) | Canon Medical Systems Corporation | 2019-06-12 |
| Low Dose Lung Screening Option (K190505) | Canon Medical Systems Corporation | 2019-06-05 |
| Vantage Galan 3T, MRT-3020/A9, V5.0 (K183657) | Canon Medical Systems Corporation | 2019-03-15 |
| Vitrea Software Package, VSTP-001A (K182601) | Canon Medical Systems Corporation | 2018-12-14 |
| Vitrea Software Package, VSTP-001A (K183013) | Canon Medical Systems Corporation | 2018-11-26 |
| Celesteion, PCA-9000A/3, V6.5 (K181646) | Canon Medical Systems Corporation | 2018-11-16 |
| Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System (K182596) | Canon Medical Systems Corporation | 2018-11-02 |
| Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427) | Canon Medical Systems Corporation | 2018-11-02 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (K182679) | Canon Medical Systems Corporation | 2018-10-31 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K182282) | Canon Medical Systems Corporation | 2018-10-19 |
| Alphenix, INFX-8000H/B, V8.0 (K182546) | Canon Medical Systems Corporation | 2018-10-17 |
| Alphenix, INFX-8000F/B, V8.0 (K182415) | Canon Medical Systems Corporation | 2018-09-28 |
| XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415) | Canon Medical Systems Corporation | 2018-09-10 |
| Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593) | Canon Medical Systems Corporation | 2018-08-13 |
| Alphenix, INFX-8000C/B, V8.0 (K181804) | Canon Medical Systems Corporation | 2018-08-02 |
| Alphenix, INFX-8000V/B, V8.0 (K181670) | Canon Medical Systems Corporation | 2018-07-25 |
| Ultimax-i, DREX-UI80 (V1.60) (K181834) | Canon Medical Systems Corporation | 2018-07-19 |
| Vitrea Software Package; VSTP-001A (K180323) | Canon Medical Systems Corporation | 2018-03-30 |