PROBEAT— 510(k) K053280

Substantially Equivalent

Hitachi, Ltd., Power Systems Group

FDA 510(k) clearance K053280 for PROBEAT, Substantially Equivalent on 2006-03-09. Applicant: Hitachi, Ltd., Power Systems Group. Device class: 2.

Clearance details

Applicant: Hitachi, Ltd., Power Systems Group
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2005-11-23
Decision date: 2006-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHN

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 Hitachi, Ltd., Power Systems Group

K073059 — PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM2007-12-10

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