# K053280: Probeat

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd., Power Systems Group
- Decided: Mar 9, 2006 after 106 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: 2 generations back to K872369 (1988). 3 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992414: Proton Beam Therapy System (PBTS), Optivus Technology, Inc. (2000) Summary page 2.
- K983024: Proton Therapy System, Ion Beam Applications S.A. (2001) Summary page 2.

## Most influential descendants
- K060834: Probeat with MGCS (2006), 17 descendants of its own
- 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
- K120676: S-250 Proton Beam Radiation Therapy System (2012), 5 descendants of its own

## Indications for use
Hitachi's PROBEAT is a medical device designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K053280
Methodology: https://510kreport.com/methodology