FDA 510(k)

Alturion Series Diagnostisches Ultraschallsystem

K-Nummer: K262311 · 2026-08-04

Entscheidungsdatum2026-08-04

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Alturion 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 2026-08-04 under 510(k) number K262311. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Alturion Series Diagnostic Ultrasound System?

Alturion Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K262311.

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

Alturion Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-08-04, under 510(k) number K262311.

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

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

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Philips Ultrasound, LLC als Antragsteller

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System K260667Alturion Series Diagnostisches Ultraschallsystem K260123EPIQ Series Diagnostic Ultrasound System K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K252558Lumify Diagnostic Ultrasound System

Alle 27 Geräte anzeigen →

Verwandte Geräte (Code: IYN)

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.