# K191801: Probeat-CR

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd.
- Decided: Sep 13, 2019 after 72 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K872369 (1988). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151132: Probeat-V, Hitachi, Ltd., Health Care Company (2015) Summary page 4.
- K152592: Probeat-V, Hitachi, Ltd., Health Care Company (2015) Summary page 4.

## Most influential descendants
- K201042: Probeat-CR (2020), 2 descendants of its own
- K260174: Probeat-CR (2026), 0 descendants of its own
- K232032: Probeat-FR (2024), 0 descendants of its own

## Recalls of this device
- Feb 6, 2026 · Class II · Z-1430-2026: Software anomaly in the patient positioning system may result in positional discrepancy.

## 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/K191801
Methodology: https://510kreport.com/methodology