Model note · CT Scanner
Canon Aquilion ONE 320 row wide area CT family
Aquilion ONE is Canon Medical's 320 row CT. A 16 cm wide detector covers whole organs such as the heart or brain in one rotation without moving the table. It was first cleared as a Toshiba product in 2006 (K063189) and has gone through several model numbers, from TSX-301A to the TSX-306A with rapid kV switching for spectral imaging. Many older Toshiba badged units are still in service beside newer Canon units.
The model
Maker, model and type.
- Maker
- Canon Medical Systems Corporation (formerly Toshiba Medical Systems)
- Model
- Aquilion ONE 320 row wide area CT family (TSX-301A to TSX-306A/3; current PRISM Edition)
- Device type
- CT Scanner
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Detector | 320 detector rows of 0.5 mm, 16 cm z axis coverage; up to 640 slices with coneXact double slice reconstruction | Source |
| Early system description (FDA recall record) | 320 row 0.5 mm detector with a 7.5 MHU large capacity X-ray tube | Source |
| TSX-306A/3 main hardware | HV generator CXXG-018A, gantry CGGT-039A, detector CDAS-052A/6A, X-ray tube CXB-750F | Source |
| Generator upgrade path | Upgrade kit CXGS-020A lets TSX-305A generators (CXXG-013A) match the TSX-306A generator | Source |
| Console software | V10.0 moved the console from Windows 7 to Windows 10 | Source |
| FDA classification and clearance | CT X-ray system, product code JAK; K192188 Aquilion ONE (TSX-306A/3) V10.0, decided 6 September 2019, predicate TSX-305A/6 V8.9 with AiCE (K183046) | Source |
| Standards listed | IEC 60601-1-6, 60601-2-28, 60601-2-44, IEC 60825-1, IEC 62304, IEC 62366, NEMA XR-25, XR-26 and XR-29 | Source |
Recalls
Known FDA recalls.
- Z-1726-20202019-03-25
eXam Plan error could interrupt scanning and block normal shutdown, losing raw data (TSX-305A/3; related records cover TSX-301A and TSX-301C).
FDA record - Z-0471-20152014-11-05
Cardiac function analysis software could show incorrect results.
FDA record - Z-0972-20142013-12-11
High voltage generator part failures could prevent X-ray exposure.
FDA record - Z-1113-20142013-10-01
X-ray output control software might set conditions wrongly so contrast scans did not start.
FDA record - Z-2895-20112011-01-07
Optical conversion connector failure broke communication between reconstruction units.
FDA record - Z-1257-20112010-09-07
Pre scan dose calculation about 10% low for 80 and 100 kV plans.
FDA record
Safety
Safety warnings from the record.
- On early TSX-301A software the pre scan dose estimate at 80 or 100 kV was about 10% lower than the dose actually delivered. Source
- Cardiac function analysis software could display incorrect whole heart function results. Source
- Contrast studies can fail if the exposure does not start at the planned time, which may mean repeat injection and dose. Source
Sources
Where this note comes from.
- Canon Medical Aquilion ONE PRISM technology page (US)
- FDA 510(k) K192188 summary, Aquilion ONE (TSX-306A/3) V10.0
- openFDA recall search, Aquilion ONE
- openFDA MAUDE problem counts, brand Aquilion ONE
Not covered: Gantry aperture, generator power, rotation time and table load were not found on an official Canon page that could be opened, so they are left out. Which marketing name (Vision, GENESIS, PRISM) maps to each TSX model number was not confirmed from an official source. Service manuals and error codes are not public, so errorCodes is empty. MAUDE holds only about a dozen reports for this brand. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
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