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FDA 510(k)

Vitrea CT Cardiac Analysis

K-Number: K222662 · 2022-10-14

ApplicantCanon Medical Informatics, Inc.
Decision Date2022-10-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea CT Cardiac Analysis is a medical device manufactured by Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2022-10-14 under approval number K222662. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitrea CT Cardiac Analysis?

Vitrea CT Cardiac Analysis is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Canon Medical Informatics, Inc.. The 510(k) number is K222662.

When was Vitrea CT Cardiac Analysis approved by the FDA?

Vitrea CT Cardiac Analysis received FDA 510(k) clearance on 2022-10-14, under approval number K222662.

What company makes Vitrea CT Cardiac Analysis?

Vitrea CT Cardiac Analysis is manufactured by Canon Medical Informatics, Inc..

What is the FDA product code for Vitrea CT Cardiac Analysis?

The FDA product code for Vitrea CT Cardiac Analysis is LLZ.

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Related PubMed Literature

PMID: 34056520 Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis. Digital biomarkers (2021)

Other Devices by Canon Medical Informatics, Inc.

K223261Open Rib K252217CT VScore+ K243240Vitrea CT VScore

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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