# K060834: Probeat with MGCS

- Pathway: 510(k) (Special)
- Applicant: Hitachi, Ltd.
- Decided: Apr 19, 2006 after 23 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: 3 generations back to K872369 (1988). 4 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 22 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 1.

## Most influential descendants
- K073059: Probeat with Discrete Spot Scanning System (2007), 16 descendants of its own
- 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

## Indications for use
Hitachi's PROBEAT with MGCS 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/K060834
Methodology: https://510kreport.com/methodology