ANZAI AZ-733 RESPIRATORY GATING SYSTEM— 510(k) K031385

Name: FDA 510(k) clearance K031385
Creator: U.S. Food and Drug Administration
Published: 2003-11-10

Substantially Equivalent

Anzai Medical Co., Ltd.

FDA 510(k) clearance K031385 for ANZAI AZ-733 RESPIRATORY GATING SYSTEM, Substantially Equivalent on 2003-11-10. Applicant: Anzai Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Anzai Medical Co., Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2003-05-01
Decision date: 2003-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, 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 Anzai Medical Co., Ltd.

view all

K170719 — Anzai Respiratory Gating System2017-04-05
K160432 — Anzai Respiratory Gating System2016-04-22
K022342 — EZ-SCOPE AN, EZ-SCOPE LIGHT2002-10-09

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