PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM— 510(k) K073059

Name: FDA 510(k) clearance K073059
Creator: U.S. Food and Drug Administration
Published: 2007-12-10

Substantially Equivalent

Hitachi, Ltd., Power Systems Group

FDA 510(k) clearance K073059 for PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM, Substantially Equivalent on 2007-12-10. 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: 2007-10-30
Decision date: 2007-12-10
Decision: Substantially Equivalent
Clearance type: Special
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

More clearances from Hitachi, Ltd., Power Systems Group

view all

K053280 — PROBEAT2006-03-09

Recalls naming K073059

K-number listed on FDA's recall record

Z-1838-2015 — PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.Class II·Terminated·Hitachi America, Ltd., Power Systems Division·20150421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073059.

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