FDA 510(k)

Dolphin Medical Imaging USB Ultrasound System

Numéro K : K192573 · 2019-11-19

Date de décision2019-11-19

Code produitIYO

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Dolphin Medical Imaging USB Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Dolphin Medical Imaging, LLC. It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K192573. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Dolphin Medical Imaging USB Ultrasound System?

Dolphin Medical Imaging USB Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Dolphin Medical Imaging, LLC. The 510(k) number is K192573.

When did Dolphin Medical Imaging USB Ultrasound System receive FDA 510(k) clearance?

Dolphin Medical Imaging USB Ultrasound System received FDA 510(k) clearance on 2019-11-19, under 510(k) number K192573.

Who is the listed applicant for Dolphin Medical Imaging USB Ultrasound System?

The FDA 510(k) record lists Dolphin Medical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dolphin Medical Imaging USB Ultrasound System?

The FDA product code for Dolphin Medical Imaging USB Ultrasound System is IYO.

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 : IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.