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FDA 510(k)

Anzai Respiratory Gating System

K-Number: K160432 · 2016-04-22

ApplicantAnzai Medical Co., Ltd.
Decision Date2016-04-22
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Anzai Respiratory Gating System is the device name listed in this FDA 510(k) record. The listed applicant is Anzai Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160432. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anzai Respiratory Gating System?

Anzai Respiratory Gating System is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Anzai Medical Co., Ltd.. The 510(k) number is K160432.

When did Anzai Respiratory Gating System receive FDA 510(k) clearance?

Anzai Respiratory Gating System received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160432.

Who is the listed applicant for Anzai Respiratory Gating System?

The FDA 510(k) record lists Anzai Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anzai Respiratory Gating System?

The FDA product code for Anzai Respiratory Gating System is LHN.

Other records listing Anzai Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170719Anzai Respiratory Gating System

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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