FDA 510(k)

Image Guidance System for Radiotherapy

Numéro K : K192405 · 2020-05-01

DemandeurJiangsu Rayer Medical Technology Co., Ltd.

Date de décision2020-05-01

Code produitIYE

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Image Guidance System for Radiotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192405. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Image Guidance System for Radiotherapy?

Image Guidance System for Radiotherapy is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. The 510(k) number is K192405.

When did Image Guidance System for Radiotherapy receive FDA 510(k) clearance?

Image Guidance System for Radiotherapy received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192405.

Who is the listed applicant for Image Guidance System for Radiotherapy?

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

What is the FDA product code for Image Guidance System for Radiotherapy?

The FDA product code for Image Guidance System for Radiotherapy is IYE.

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 NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : IYE)

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

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.