# K983332: Northeast Proton Therapy Center

- Pathway: 510(k) (Traditional)
- Applicant: Massachusetts General Hospital
- Decided: Jul 20, 2001 after 1,032 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- 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.
8 later devices descend from it; 2 cite it directly.
0 of 10 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 1.
- (no number) Harvard University Cyclotron Laboratory’s Proton Beam Therapy Center: named in the summary without a submission number

## Most influential descendants
- 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
- K172848: MEVION S250i Proton Beam Radiation Therapy Device (2017), 2 descendants of its own
- K250986: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (2025), 1 descendant of its own
- K130426: Sumitomo Proton Therapy System (2013), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K983332
Methodology: https://510kreport.com/methodology