510(k) · Cleared

Cleared

Northeast Proton Therapy Center

K983332510(k) TraditionalCleared Jul 20, 20011,032-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

Massachusetts General Hospital · LHN System, Radiation Therapy, Charged-Particle, Medical

Cleared on Jul 20, 2001 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) after a 1,032-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.

Decided: Jul 20, 2001
Review: 1,032 days
Class: Class II
Product code: LHN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872369 (1988). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
This deviceK983332 Northeast Proton Therapy CenterMassachusetts General Hospital · 2001
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 · cites it directly · 1 of its ownK130426 Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012high 2 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · 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
K130426Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. · 2013 · cites it directly1descendant

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)	K983332	Northeast Proton Therapy Center	Massachusetts General Hospital	2001	—
+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	—
+1	K130426	Sumitomo Proton Therapy System	Sumitomo Heavy Industries, Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2016	2	0
2017	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K983332, 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

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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 …Name Medical Charged-Particle Radiation Therapy System (21 C.F.R. § 892.5050) Predicate Devices () Loma Linda University Medical Center’s Proton Beam Therapy Center (K872369) : (2) Harvard University Cyclotron Laboratory’s Proton Beam Therapy Center (preamendments device) Intended Use The Northeast…	Loma Linda University Medical Center	1988	—
*	—	Harvard University Cyclotron Laboratory’s Proton Beam Therapy Center Named without a submission number			—

Also cleared against K872369: 8 other devices →

What descends from it? (8)

2 later devices cite 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
K130426	Sumitomo Proton Therapy System	Sumitomo Heavy Industries, Ltd.	2013	1

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?

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 NPTC is a facility intended to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized tumors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient’s treatment site.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983332: Northeast Proton Therapy Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983332

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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