# K073059: Probeat with Discrete Spot Scanning System

- Pathway: 510(k) (Special)
- Applicant: Hitachi, Ltd., Power Systems Group
- Decided: Dec 10, 2007 after 41 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: 4 generations back to K872369 (1988). 7 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053280: Probeat, Hitachi, Ltd., Power Systems Group (2006) Summary page 2.
- K060834: Probeat with MGCS, Hitachi, Ltd. (2006) Summary page 2.
- K060695: Iba Proton Therapy System - Proteus 235, Ion Beam Applications S.A. (2006) Summary page 2.

## Most influential descendants
- K151132: Probeat-V (2015), 10 descendants of its own
- K152592: Probeat-V (2015), 7 descendants of its own
- K134052: Radiance 330 Proton Therapy System (2014), 4 descendants of its own
- K191801: Probeat-CR (2019), 3 descendants of its own
- K201042: Probeat-CR (2020), 2 descendants of its own

## Recalls of this device
- Apr 21, 2015 · Class II · Z-1838-2015: At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control sy

## Indications for use
Hitachi's PROBEAT with DSSS 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/K073059
Methodology: https://510kreport.com/methodology