K260811
- 510(k) number
- K260811
- Device name
- Heartvue.Proton
- Applicant
- Heartvue.ai, Inc. TN · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-08-26
- Date received
- 2026-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K260811.pdf
Official FDA record: K260811
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.