Cleared Traditional

Vitrea CT VScore

K243240 · Canon Medical Informatics, Inc. · Radiology

Apr 2025

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K243240 is an FDA 510(k) clearance for the Vitrea CT VScore, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Canon Medical Informatics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 10, 2025, 182 days after receiving the submission on October 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K243240 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2024
Decision Date	April 10, 2025
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF