Aquilion ONE (TSX-308A/TSX-306A) V2.0— 510(k) K253596
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K253596 for Aquilion ONE (TSX-308A/TSX-306A) V2.0, Substantially Equivalent on 2026-05-20. Applicant: Canon Medical Systems Corporation. Device class: 2.
Summary
Canon Medical Systems' Aquilion ONE (TSX-308A/TSX-306A) V2.0 is filed under JAK, computed tomography x-ray systems.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Canon filed from Otawara-Shi, Japan. Review took 183 calendar days (November 18, 2025 to May 20, 2026).
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Recent devices under product code JAK
view allMore clearances from Canon Medical Systems Corporation
view all- K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K260078 — Aquilion ServeSP (TSX-307B) V2.0
- K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
- K251370 — Cartesion Prime (PCD-1000A/3) V10.21
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.