ProNova SC360 Proton Therapy System— 510(k) K162246

Name: FDA 510(k) clearance K162246
Creator: U.S. Food and Drug Administration
Published: 2016-12-08

Substantially Equivalent

Pronova Solutions, LLC

FDA 510(k) clearance K162246 for ProNova SC360 Proton Therapy System, Substantially Equivalent on 2016-12-08. Applicant: Pronova Solutions, LLC. Device class: 2.

Clearance details

Applicant: Pronova Solutions, LLC
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-08-10
Decision date: 2016-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maryville, TN, 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.