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FDA 510(k)

Canvas Dx

K-Number: K243558 · 2025-04-11

ApplicantCognoa, Inc.
Decision Date2025-04-11
Product CodeQPF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Canvas Dx is a medical device manufactured by Cognoa, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval number K243558. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Canvas Dx?

Canvas Dx is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Cognoa, Inc.. The 510(k) number is K243558.

When was Canvas Dx approved by the FDA?

Canvas Dx received FDA 510(k) clearance on 2025-04-11, under approval number K243558.

What company makes Canvas Dx?

Canvas Dx is manufactured by Cognoa, Inc..

What is the FDA product code for Canvas Dx?

The FDA product code for Canvas Dx is QPF.

Other Devices by Cognoa, Inc.

Related Devices (Code: QPF)

Official Source

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