FDA 510(k)

Real Time Image Gating System for Proton Beam Therapy Systems

Numéro K : K171049 · 2017-12-26

Date de décision2017-12-26

Code produitLHN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Real Time Image Gating System for Proton Beam Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Healthcare. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K171049. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Hitachi, Ltd. Healthcare. The 510(k) number is K171049.

When did Real Time Image Gating System for Proton Beam Therapy Systems receive FDA 510(k) clearance?

Real Time Image Gating System for Proton Beam Therapy Systems received FDA 510(k) clearance on 2017-12-26, under 510(k) number K171049.

Who is the listed applicant for Real Time Image Gating System for Proton Beam Therapy Systems?

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

What is the FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems is LHN.

Essais cliniques associés

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Dispositifs connexes (Code : LHN)

K260597VIRTUE QAProNova Solutions 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.

Source officielle

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