Devices · Canon Medical Systems Corporation

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

Canon Medical Systems Corporation is listed for Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (K213504). The FDA list gives June 16, 2022 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JAK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213504

Official FDA database record

Date of final decision

June 16, 2022

Company on the FDA list

Canon Medical Systems Corporation

Lead panel

Radiology

Primary product code

JAK

openFDA device name for the code

System, X-Ray, Tomography, Computed

Device class

2

Regulation number

892.1750

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary