Vitrea CT Cardiac Analysis

FDA 510(k) K222662 · Canon Medical Informatics, Inc.

Substantially Equivalent

510(k) numberK222662

Submission

Device name
Vitrea CT Cardiac Analysis
Applicant
Canon Medical Informatics, Inc.
Minnetonka, MN, US
Received
September 2, 2022
Decision date
October 14, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Vitrea CT Cardiac Analysis cleared by the FDA?

Vitrea CT Cardiac Analysis (K222662) received a 510(k) decision of Substantially Equivalent on October 14, 2022, 42 days after the submission was received.

What is the product code of K222662?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.