Sumitomo Proton Therapy System— 510(k) K160612

Name: FDA 510(k) clearance K160612
Creator: U.S. Food and Drug Administration
Published: 2016-08-17

Substantially Equivalent

Sumitomo Heavy Industries, Ltd.

FDA 510(k) clearance K160612 for Sumitomo Proton Therapy System, Substantially Equivalent on 2016-08-17. Applicant: Sumitomo Heavy Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Sumitomo Heavy Industries, Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-03-03
Decision date: 2016-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niihama, JP

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

More clearances from Sumitomo Heavy Industries, Ltd.

view all

K130426 — SUMITOMO PROTON THERAPY SYSTEM2013-11-19

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