FDA 510(k)

Radiance 330 Proton Beam Therapy System

Numéro K : K191521 · 2019-09-27

DemandeurProtom International Holding Corporation

Date de décision2019-09-27

Code produitLHN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Radiance 330 Proton Beam Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Protom International Holding Corporation. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K191521. 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 Radiance 330 Proton Beam Therapy System?

Radiance 330 Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Protom International Holding Corporation. The 510(k) number is K191521.

When did Radiance 330 Proton Beam Therapy System receive FDA 510(k) clearance?

Radiance 330 Proton Beam Therapy System received FDA 510(k) clearance on 2019-09-27, under 510(k) number K191521.

Who is the listed applicant for Radiance 330 Proton Beam Therapy System?

The FDA 510(k) record lists Protom International Holding Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiance 330 Proton Beam Therapy System?

The FDA product code for Radiance 330 Proton Beam Therapy System 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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