Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Cognoa, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Cognoa, Inc.. The 510(k) number is K243558.

When did Canvas Dx receive FDA 510(k) clearance?

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

Who is the listed applicant for Canvas Dx?

The FDA 510(k) record lists Cognoa, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canvas Dx?

The FDA product code for Canvas Dx is QPF.

Related Devices (Code: QPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253442EarliPoint AssessmentEarlitec DiagnosticsK243891EarliPoint SystemEarlitec DiagnosticsK230337EarliPointEarlitec Diagnostics, Inc.K213882EarliPoint SystemEarlitec Diagnostics, Inc.

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.

↑