Heartvue.Proton— 510(k) K260811

Substantially Equivalent

Heartvue.ai, Inc.

FDA 510(k) clearance K260811 for Heartvue.Proton, Substantially Equivalent on 2026-08-26. Applicant: Heartvue.ai, Inc.. Device class: 2.

Clearance details

Applicant: Heartvue.ai, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-03-12
Decision date: 2026-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.