# K260811: Heartvue.Proton

- Pathway: 510(k) (Traditional)
- Applicant: Heartvue.ai, Inc.
- Decided: Aug 26, 2026 after 167 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940172 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 6.

## Indications for use
Heartvue.Proton is indicated for use in clinical settings where quantified results are needed to support the visualization and analysis of MR images of the heart and blood vessels for use on individual patients with cardiovascular disease. When the quantified results provided by Heartvue.Proton are used in a clinical setting on MR images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K260811
Methodology: https://510kreport.com/methodology