Heartvue.Proton— 510(k) K260811
Substantially EquivalentHeartvue.ai, Inc.
FDA 510(k) clearance K260811 for Heartvue.Proton, Substantially Equivalent on 2026-08-26. Applicant: Heartvue.ai, Inc.. Device class: 2.
Summary
Heartvue.ai's Heartvue.Proton is filed under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
The applicant filed from Brentwood, Tennessee. The decision came 167 calendar days after FDA received it (March 12 to August 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Heartvue.ai, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brentwood, TN, US
Recent devices under product code QIH
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