NORTHEAST PROTON THERAPY CENTER— 510(k) K983332

Name: FDA 510(k) clearance K983332
Creator: U.S. Food and Drug Administration
Published: 2001-07-20

Substantially Equivalent

Massachusetts General Hospital

FDA 510(k) clearance K983332 for NORTHEAST PROTON THERAPY CENTER, Substantially Equivalent on 2001-07-20. Applicant: Massachusetts General Hospital. Device class: 2.

Clearance details

Applicant: Massachusetts General Hospital
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1998-09-22
Decision date: 2001-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHN

view all

K260174 — PROBEAT-CR2026-06-11
K252815 — ProBeam 360 Proton Therapy System v3.02026-04-23
K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)2026-03-25
K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)2025-09-12
K243900 — eMotus Respiratory Motion Management System2025-06-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.