Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

Canon Medical Systems Corporation · K213504 · 2022-06-16

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K213504) with a decision date of 2022-06-16. Review panel: Radiology.

FDA submission numberK213504
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2022-06-16
DecisionSubstantially Equivalent
Product codeJAK
ClassificationSystem, X-Ray, Tomography, Computed
Device class2
Regulation number892.1750
Review time (calendar days)227
Applicant countryJP

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.