# K082416: Iba Proton Therapy System- Proteus 235

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Dec 12, 2008 after 113 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- 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.
17 later devices descend from it; 3 cite it directly.
0 of 19 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
- K101294: PT2 Varian Proton Therapy System (2010), 10 descendants of its own
- K120676: S-250 Proton Beam Radiation Therapy System (2012), 5 descendants of its own
- K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (2016), 4 descendants of its own
- K134052: Radiance 330 Proton Therapy System (2014), 4 descendants of its own
- K133191: Probeam Proton Therapy System (2014), 3 descendants of its own

## Recalls of this device
- Oct 19, 2017 · Class II · Z-0931-2018: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
- Mar 27, 2014 · Class II · Z-0020-2015: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the c
- Dec 4, 2013 · Class II · Z-1492-2014: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

## 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/K082416
Methodology: https://510kreport.com/methodology