Cleared Special

Vitrea CT Cardiac Analysis

K222662 · Canon Medical Informatics, Inc. · Radiology
Oct 2022
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K222662 is an FDA 510(k) clearance for the Vitrea CT Cardiac Analysis, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Canon Medical Informatics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 14, 2022, 42 days after receiving the submission on September 2, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K222662 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2022
Decision Date October 14, 2022
Days to Decision 42 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050