# K153614: PROBEAT-V and accessories

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd., Health Care Company
- Decided: Apr 21, 2016 after 126 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: 7 generations back to K872369 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.

## 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. The PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K153614
Methodology: https://510kreport.com/methodology