510(k) · Cleared

Recalled · Class II · 2017

Iba Proton Therapy System- Proteus 235

K082416510(k) TraditionalCleared Dec 12, 2008113-day reviewClass II21 CFR 892.5050Recalls 3

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 Dec 12, 2008 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) after a 113-day review. Its family tree reaches back 1 generation to 1988. 17 later devices descend from it. It has been recalled 3 times.

Decided: Dec 12, 2008
Review: 113 days
Class: Class II
Product code: LHN
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K872369 (1988). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
This deviceK082416 Iba Proton Therapy System- Proteus 235Ion Beam Applications S.A. · 2008
Descendant · cites it directly · 10 of its ownK101294 PT2 Varian Proton Therapy SystemVarian Medical Systems, Oncology Systems · 2010
Descendant · 2 generations on · 5 of its ownK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
Descendant · 3 generations on · 4 of its ownK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
Descendant · cites it directly · 4 of its ownK134052 Radiance 330 Proton Therapy SystemProtom International, Inc. · 2014
Descendant · 2 generations on · 3 of its ownK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2010high 2 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all

K101294PT2 Varian Proton Therapy SystemVarian Medical Systems, Oncology Systems · 2010 · cites it directly10descendants
K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · 2 generations on5descendants
K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016 · 3 generations on4descendants
K134052Radiance 330 Proton Therapy SystemProtom International, Inc. · 2014 · cites it directly4descendants
K133191Probeam Proton Therapy SystemVarian Medical Systems · 2014 · 2 generations on3descendants

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)	K082416	Iba Proton Therapy System- Proteus 235	Ion Beam Applications S.A.	2008	—
+1	K101294	PT2 Varian Proton Therapy System	Varian Medical Systems, Oncology Systems	2010	—
+2	K120676	S-250 Proton Beam Radiation Therapy System	Mevion Medical Systems	2012	12
+3	K152224	Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)	Ion Beam Application S.A.	2016	7
+1	K134052	Radiance 330 Proton Therapy System	Protom International, Inc.	2014	—
+2	K133191	Probeam Proton Therapy System	Varian Medical Systems	2014	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2013	1	0
2014	2	0
2016	2	0
2017	2	0
2019	1	0
2022	1	0
2023	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K082416, 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 2 …age 2 === 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? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101294	PT2 Varian Proton Therapy System	Varian Medical Systems, Oncology Systems	2010	10
K134052	Radiance 330 Proton Therapy System	Protom International, Inc.	2014	4
K124002	Verification Console	Varian Medical Systems	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 19, 2017	Class II	Z-0931-2018	Device Design	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	Device Design	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 cyclotron to accelerate protons) may…
Dec 4, 2013	Class II	Z-1492-2014	Software design	Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K101294 (Varian Medical Systems, Oncology Systems, 2010) has gone furthest, with 10 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. 2008, 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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082416 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082416: 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/K082416

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