FDA 510(k)

McLaren Proton Therapy System

Numéro K : K160063 · 2016-02-25

DemandeurMclaren Health Care Corporation

Date de décision2016-02-25

Code produitLHN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

McLaren Proton Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Mclaren Health Care Corporation. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K160063. 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 McLaren Proton Therapy System?

McLaren Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Mclaren Health Care Corporation. The 510(k) number is K160063.

When did McLaren Proton Therapy System receive FDA 510(k) clearance?

McLaren Proton Therapy System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K160063.

Who is the listed applicant for McLaren Proton Therapy System?

The FDA 510(k) record lists Mclaren Health Care Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for McLaren Proton Therapy System?

The FDA product code for McLaren Proton Therapy System is LHN.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.