Anzai Respiratory Gating System— 510(k) K170719

Name: FDA 510(k) clearance K170719
Creator: U.S. Food and Drug Administration
Published: 2017-04-05

Substantially Equivalent

Anzai Medical Co., Ltd.

FDA 510(k) clearance K170719 for Anzai Respiratory Gating System, Substantially Equivalent on 2017-04-05. 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: 2017-03-09
Decision date: 2017-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Tokyo, 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 Anzai Medical Co., Ltd.

view all

K160432 — Anzai Respiratory Gating System2016-04-22
K031385 — ANZAI AZ-733 RESPIRATORY GATING SYSTEM2003-11-10
K022342 — EZ-SCOPE AN, EZ-SCOPE LIGHT2002-10-09

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