# K151132: Probeat-V

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd., Health Care Company
- Decided: Jun 1, 2015 after 34 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: 5 generations back to K872369 (1988). 8 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073059: Probeat with Discrete Spot Scanning System, Hitachi, Ltd., Power Systems Group (2007) Summary page 4.

## Most influential descendants
- K152592: Probeat-V (2015), 7 descendants of its own
- K191801: Probeat-CR (2019), 3 descendants of its own
- 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
- Apr 15, 2019 · Class II · Z-1892-2019: There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

## Indications for use
The PROBEAT-V 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/K151132
Methodology: https://510kreport.com/methodology