# K992414: Proton Beam Therapy System (PBTS)

- Pathway: 510(k) (Traditional)
- Applicant: Optivus Technology, Inc.
- Decided: Jul 21, 2000 after 367 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: 1 generation back to K872369 (1988). 1 ancestor in all.
27 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872369: Loma Linda Univ. Proton Beam Therapy System, Loma Linda University Medical Center (1988) Summary page 1.

## Most influential descendants
- K053280: Probeat (2006), 26 descendants of its own
- 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

## Indications for use
The Optivus Technology, Inc.’s Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects the patient from unnecessary exposure to radiation and other hazards.

Source page: https://510kreport.com/device/K992414
Methodology: https://510kreport.com/methodology