510(k) clearance

Heartvue.Proton

FDA 510(k) source

510(k) number

K260811

Applicant

Heartvue.ai, Inc.

Decision date

Aug 26, 2026

Date received

Mar 12, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QIH

Device type

Automated Radiological Image Processing Software

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Brentwood, TN, US