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FDA 510(k)

CT VScore+

K-Number: K252217 · 2025-11-28

ApplicantCanon Medical Informatics, Inc.
Decision Date2025-11-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT VScore+ is a medical device manufactured by Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2025-11-28 under approval number K252217. 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 CT VScore+?

CT VScore+ is a medical device that received FDA 510(k) clearance on 2025-11-28. It is manufactured by Canon Medical Informatics, Inc.. The 510(k) number is K252217.

When was CT VScore+ approved by the FDA?

CT VScore+ received FDA 510(k) clearance on 2025-11-28, under approval number K252217.

What company makes CT VScore+?

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

What is the FDA product code for CT VScore+?

The FDA product code for CT VScore+ is JAK.

Other Devices by Canon Medical Informatics, Inc.

K222662Vitrea CT Cardiac Analysis K223261Open Rib 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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