510(k) · Cleared

Cleared

Iba Proton Therapy System, Model Proteus 235

K100766510(k) TraditionalCleared Jul 21, 2010126-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ion Beam Applications S.A. · LHN System, Radiation Therapy, Charged-Particle, Medical

Cleared on Jul 21, 2010 as substantially equivalent to K983024 (Ion Beam Applications S.A., 2001) after a 126-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jul 21, 2010
Review: 126 days
Class: Class II
Product code: LHN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K872369 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
1 generation backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
This deviceK100766 Iba Proton Therapy System, Model Proteus 235Ion Beam Applications S.A. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K872369	Loma Linda Univ. Proton Beam Therapy System	Loma Linda University Medical Center	1988	—
−1	K983024	Proton Therapy System	Ion Beam Applications S.A.	2001	—
0 (this device)	K100766	Iba Proton Therapy System, Model Proteus 235	Ion Beam Applications S.A.	2010	—

FIG. 1 — Lineage of K100766, 1988–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LHN device

#1 K260597 Virtue QAscore 15.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K983024	Proton Therapy System Summary page 2 …arged-particle radiation therapy systems. (21 C.F.R. §892.5050) Predicate Device The PTS is substantially equivalent to the previously cleared IBA proton therapy system (K983024). The current PTS and its predicate device have the same intended use and principles of operation, and are substantially equivale…	Ion Beam Applications S.A.	2001	—

Also cleared against K983024: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
None of the 2 ancestors has a recall.
7 other devices also cite its predicate K983024.

How does its category compare?

All LHN devices

LHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LHN

3in 2025

2007high 7 (2016) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHN

190in 2025

2007high 194 (2026) · low 53 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LHN

1in 2023

2007high 5 (2017) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LHN

11in 2025

2007high 24 (2021) · low 0 (2007)2025

MAUDE reports naming product code LHN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	2	0
2008	3	113	2	1
2009	5	69	0	5
2010	4	96	0	3
2011	1	—	0	1
2012	3	111	0	1
2013	3	70	0	1
2014	4	93	2	5
2015	3	53	1	2
2016	7	120	0	1
2017	4	173	5	7
2018	3	78	2	8
2019	2	—	0	3
2020	4	74	1	20
2021	0	—	1	24
2022	2	—	2	10
2023	2	—	1	7
2024	1	—	0	2
2025	3	190	0	11
2026	4	194	0	—

What is it indicated for?

The Proton Therapy System - Proteus 235 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.

The PTS may include a Fixed Small beam Treatment Room dedicated to treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localised to the head and neck.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100766 · printed Nov 3, 2026

Cite this page

510(k) Report. “K100766: Iba Proton Therapy System, Model Proteus 235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100766

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026