All AI devices
US

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

🇯🇵Canon Medical Systems Corporation · System, X-Ray, Tomography, Computed

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K192828
Product codeJAK
Decision dateFeb 13, 2020
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk class
Notified body
EMDN code
Basic UDI-DI
AI Act class

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Founded1930-01-01 · via wikidata

Cite this page

RadPigeon. "Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (Canon Medical Systems Corporation)." AI Devices registry. https://radpigeon.news/ai/device/aquilion-one-tsx-306a-3-v10-0-with-spectral-imaging-system

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.