# Canon Medical Systems Corporation

- Location (FDA's records): Otawara-Shi, JP
- FDA decisions: 97 (2018–2026): 97 510(k) clearances
- Product codes: LNH (31), JAK (23), IYN (17), OWB (12), LLZ (7), KPS (5), QIH (1), JAA (1)
- 510(k) review time since 2016: median 84 days, against 105 for FDA's reviews in the same codes and years (58 of 96 faster)
- Predicates its devices cite: 110 (77 its own); citations of its devices by later devices: 77 (77 its own)
- Recalls linked to its devices: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Toshibamedical Systems Corporation: 23 (https://510kreport.com/company/toshibamedical-systems)
- Toshiba America Medical Systems, In.C: 3 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Philips Medical Systems Nederland B.V.: 3 (https://510kreport.com/company/philips-medical-systems-nederland)
- Canon Medical Systems, USA: 1 (https://510kreport.com/company/canon-medical-systems-usa)
- Toshiba Medical Systems Coroporation: 1 (https://510kreport.com/company/toshiba-medical-systems-coroporation)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Supersonic Imagine: 1 (https://510kreport.com/company/supersonic-imagine)

## Its most-cited devices
- K193021: Vantage Orian 1.5T, MRT-1550, V6.0 (2020), cited by 3
- K181593: Vantage Galan 3T, MRT-3020/A7, V5.0 (2018), cited by 3
- K242808: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (2025), cited by 2
- K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (2022), cited by 2
- K242403: Aquilion ONE (TSX-308A/3) V1.5 (2024), cited by 2
- K182282: Vantage Orian 1.5T, MRT-1550, V4.5 (2018), cited by 2

## Recent decisions
- K253596: Aquilion ONE (TSX-308A/TSX-306A) V2.0 (May 20, 2026)
- K253625: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (Mar 27, 2026)
- K260078: Aquilion ServeSP (TSX-307B) V2.0 (Mar 13, 2026)
- K253584: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (Mar 10, 2026)
- K253597: Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (Jan 20, 2026)
- K251370: Cartesion Prime (PCD-1000A/3) V10.21 (Dec 1, 2025)
- K252074: Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (Oct 31, 2025)
- K251602: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (Oct 10, 2025)

Source page: https://510kreport.com/company/canon-medical-systems