# K083058: Iba Proton Therapy System - Proteus 235

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Apr 15, 2009 after 183 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.
- (no number) Harvard University Cyclotron Laboratory Proton Beam Therapy device: named in the summary without a submission number

## Most influential descendants
- K162246: ProNova SC360 Proton Therapy System (2016), 0 descendants of its own

## Indications for use
The PTS is a medical device designed to product 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/K083058
Methodology: https://510kreport.com/methodology