510(k) · Cleared

Recalled · Class II · 2021

Iba Proton Therapy System - Proteus 235

K061913510(k) SpecialCleared Jul 28, 200622-day reviewClass II21 CFR 892.5050Recalls 1

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 28, 2006 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) after a 22-day review. Its family tree reaches back 1 generation to 1988. 6 later devices descend from it. It has been recalled once.

Decided: Jul 28, 2006
Review: 22 days
Class: Class II
Product code: LHN
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K872369 (1988). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
This deviceK061913 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006
Descendant · cites it directly · 5 of its ownK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
Descendant · 2 generations on · 4 of its ownK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
Descendant · 2 generations on · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
Descendant · 3 generations on · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
Descendant · 4 generations on · 0 of its ownK253406 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012high 2 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all

K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · cites it directly5descendants
K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016 · 2 generations on4descendants
K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · 2 generations on2descendants
K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025 · 3 generations on1descendant
K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872369	Loma Linda Univ. Proton Beam Therapy System	Loma Linda University Medical Center	1988	—
0 (this device)	K061913	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	2006	—
+1	K120676	S-250 Proton Beam Radiation Therapy System	Mevion Medical Systems	2012	12
+2	K152224	Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)	Ion Beam Application S.A.	2016	7
+2	K172848	MEVION S250i Proton Beam Radiation Therapy Device	Mevion Medical Systems	2017	5
+3	K250986	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	Mevion Medical Systems, Inc.	2025	—
+4	K253406	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	Mevion Medical Systems, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2016	1	0
2017	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K061913, 1988–2026Source: 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? (2)

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
*	K872369	Loma Linda Univ. Proton Beam Therapy System Summary page 1 …Predicate Devices The PTS is substantially equivalent to the previously cleared Loma Linda University Medical Center ("Loma Linda") Proton Beam Therapy device (K872369) and the Harvard University Cyclotron Laboratory Proton Beam Therapy device, a pre-1976 device. The PTS and its predicate devices…	Loma Linda University Medical Center	1988	—
*	—	Harvard University Cyclotron Laboratory Proton Beam Therapy device Named without a submission number			—

Also cleared against K872369: 8 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120676	S-250 Proton Beam Radiation Therapy System	Mevion Medical Systems	2012	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 14, 2021	Class II	Z-2434-2021	Device Design	Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K120676 (Mevion Medical Systems, 2012) has gone furthest, with 5 descendants of its own.
8 other devices also cite its predicate K872369.

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.

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 PTS 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061913 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061913: Iba Proton Therapy System - Proteus 235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061913

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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