# K260174: Probeat-CR

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi High-Tech Corp.
- Decided: Jun 11, 2026 after 141 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K872369 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201042: Probeat-CR, Hitachi, Ltd. (2020) Summary page 5.

## Indications for use
The PROBEAT-CR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K260174
Methodology: https://510kreport.com/methodology