FDA 510(k)

Kit de base de balayage auto-propulsé Aquilion ONE pour IVR-CT, CGBA-034A

Numéro K : K182223 · 2018-09-14

Date de décision2018-09-14

Code produitJAK

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems, USA. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K182223. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Canon Medical Systems, USA. The 510(k) number is K182223.

When did Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A receive FDA 510(k) clearance?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A received FDA 510(k) clearance on 2018-09-14, under 510(k) number K182223.

Who is the listed applicant for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA 510(k) record lists Canon Medical Systems, USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is JAK.

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.

NCT07608549Étude pilote de phase 1 sur la sécurité du FLASHNOT_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 : JAK)

K261125BodyTom 64 (NL4100) ; OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Bordure Améliorée pour PCCTGe Medical Systems, LLC

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.