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FDA 510(k)

Vitrea CT VScore

K-Number: K243240 · 2025-04-10

ApplicantCanon Medical Informatics, Inc.
Decision Date2025-04-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea CT VScore is a medical device manufactured by Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2025-04-10 under approval number K243240. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitrea CT VScore?

Vitrea CT VScore is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Canon Medical Informatics, Inc.. The 510(k) number is K243240.

When was Vitrea CT VScore approved by the FDA?

Vitrea CT VScore received FDA 510(k) clearance on 2025-04-10, under approval number K243240.

What company makes Vitrea CT VScore?

Vitrea CT VScore is manufactured by Canon Medical Informatics, Inc..

What is the FDA product code for Vitrea CT VScore?

The FDA product code for Vitrea CT VScore is JAK.

Other Devices by Canon Medical Informatics, Inc.

K222662Vitrea CT Cardiac Analysis K223261Open Rib K252217CT 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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