FDA-cleared K183046
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-06-12
Vendor
Canon Medical Systems Corporation
38 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K182901
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-07-05
FDA-cleared K192828
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-02-13
FDA-cleared K192832
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-02-21
FDA-cleared K192574
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-03-09
FDA-cleared K193097
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-07-14
FDA-cleared K203042
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-10
FDA-cleared K201836
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-01-12
FDA-cleared K202767
Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-01-15
FDA-cleared K203323
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-03-04
FDA-cleared K203225
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-24
FDA-cleared K203314
Cartesion Prime (PCD-1000A/3) V10.8
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-04-23
FDA-cleared K211828
Aquilion Exceed LB
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-09-10
FDA-cleared K213305
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-12-01
FDA-cleared K212333
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-24
FDA-cleared K212960
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-03-22
FDA-cleared K220192
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-04-08
FDA-cleared K213504
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-06-16
FDA-cleared K220986
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-09-12
FDA-cleared K222819
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-03
FDA-cleared K223726
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-07
FDA-cleared K230355
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-08-30
FDA-cleared K231748
Cartesion Prime (PCD-1000A/3) V10.15
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-09-12
FDA-cleared K232526
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation
Image analysis/processing for Vascular using Fluoroscopy/Angiography.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- Vascular
- Decision
- 2023-09-12
FDA-cleared K231281
Aquilion Serve (TSX-307A/1) V1.3
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-09-19
FDA-cleared K233334
Aquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-06
FDA-cleared K233195
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-01-24
FDA-cleared K232835
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-04-02
FDA-cleared K240238
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-12
FDA-cleared K241496
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-20
FDA-cleared K241582
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-09-12
FDA-cleared K242403
Aquilion ONE (TSX-308A/3) V1.5
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-23
FDA-cleared K243335
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-07
FDA-cleared K250328
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-04-30
FDA-cleared K250901
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-22
FDA-cleared K251602
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-10-10
FDA-cleared K252074
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-31
FDA-cleared K251370
Cartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-12-01