Aquilion ServeSP (TSX-307B) V2.0— 510(k) K260078
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K260078 for Aquilion ServeSP (TSX-307B) V2.0, Substantially Equivalent on 2026-03-13. Applicant: Canon Medical Systems Corporation. Device class: 2.
Summary
Canon Medical Systems' Aquilion ServeSP (TSX-307B) V2.0 is filed under JAK, computed tomography x-ray systems. The record doesn't describe the scanner beyond its name and that code name.
Class II, 21 CFR 892.1750. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Canon Medical Systems filed from Tustin, California. The decision came 60 calendar days after FDA received it (January 12 to March 13, 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
- Tustin, CA, US
Recent devices under product code JAK
view allMore clearances from Canon Medical Systems Corporation
view all- K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0
- K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- 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.