Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

97 results for "Canon Medical Systems Corporation"
1–24 of 97
Search insights Median review: 84d Cleared: 100% Top manufacturer: Canon Medical Systems Corporation Lead specialty: Radiology
Cleared May 20, 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · JAK
Canon Medical Systems Corporation
Radiology · 183d
Cleared Mar 27, 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K253625 · LNH
Canon Medical Systems Corporation
Radiology · 129d
Cleared Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · JAK
Canon Medical Systems Corporation
Radiology · 60d
Cleared Mar 10, 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · OWB
Canon Medical Systems Corporation
Radiology · 113d
Cleared Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · IYN
Canon Medical Systems Corporation
Radiology · 63d
Cleared Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · KPS
Canon Medical Systems Corporation
Radiology · 213d
Cleared Oct 31, 2025
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K252074 · IYN
Canon Medical Systems Corporation
Radiology · 121d
Cleared Oct 10, 2025
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K251602 · OWB
Canon Medical Systems Corporation
Radiology · 136d
Cleared Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
K251645 · JAK
Canon Medical Systems Corporation
Radiology · 120d
Cleared Jul 22, 2025
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K250901 · LNH
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jun 20, 2025
CT Scanner TSX-501R/1 V11.1
K243398 · JAK
Canon Medical Systems Corporation
Radiology · 232d
Cleared May 13, 2025
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
K242808 · IYN
Canon Medical Systems Corporation
Radiology · 238d
Cleared Apr 30, 2025
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
K250328 · QIH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Dec 23, 2024
Aquilion ONE (TSX-308A/3) V1.5
K242403 · JAK
Canon Medical Systems Corporation
Radiology · 132d
Cleared Sep 12, 2024
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900,...
K241582 · IYN
Canon Medical Systems Corporation
Radiology · 101d
Cleared Aug 30, 2024
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
K233107 · OWB
Canon Medical Systems Corporation
Radiology · 338d
Cleared Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K241496 · LNH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction...
K240238 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 02, 2024
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
K232835 · JAK
Canon Medical Systems Corporation
Radiology · 201d
Cleared Jan 24, 2024
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
K233195 · IYN
Canon Medical Systems Corporation
Radiology · 118d
Cleared Dec 06, 2023
Aquilion Serve SP (TSX-307B/1) V1.3
K233334 · JAK
Canon Medical Systems Corporation
Radiology · 68d
Cleared Nov 21, 2023
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
K232988 · IYN
Canon Medical Systems Corporation
Radiology · 60d