FDA 510(k)

EPIQ Series Diagnostic Ultrasound System

Numéro K : K260123 · 2026-05-27

Date de décision2026-05-27

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

EPIQ Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260123. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EPIQ Series Diagnostic Ultrasound System?

EPIQ Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K260123.

When did EPIQ Series Diagnostic Ultrasound System receive FDA 510(k) clearance?

EPIQ Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260123.

Who is the listed applicant for EPIQ Series Diagnostic Ultrasound System?

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

What is the FDA product code for EPIQ Series Diagnostic Ultrasound System?

The FDA product code for EPIQ Series Diagnostic Ultrasound System is IYN.

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

Autres dossiers indiquant Philips Ultrasound, LLC en tant que demandeur

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K262311Alturion Série Système d'Imagerie Ultrasonore Diagnostique K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System K260667Alturion Série Système d'Imagerie Ultrasonore Diagnostique K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K252558Lumify Diagnostic Ultrasound System

Voir tous les 27 dispositifs →

Dispositifs connexes (Code : IYN)

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.