# K181676: Mini Ridge Filter and auxiliary functions for PROBEAT-V

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Ltd. Healthcare Hitachi Works
- Decided: Aug 15, 2018 after 51 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.

Source page: https://510kreport.com/device/K181676
Methodology: https://510kreport.com/methodology