FDA 510(k)

Sonosite LX and Sonosite PX Ultrasound Systems

K-Nummer: K251106 · 2025-08-29

Entscheidungsdatum2025-08-29

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Sonosite LX and Sonosite PX Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251106. 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 Sonosite LX and Sonosite PX Ultrasound Systems?

Sonosite LX and Sonosite PX Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K251106.

When did Sonosite LX and Sonosite PX Ultrasound Systems receive FDA 510(k) clearance?

Sonosite LX and Sonosite PX Ultrasound Systems received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251106.

Who is the listed applicant for Sonosite LX and Sonosite PX Ultrasound Systems?

The FDA 510(k) record lists FUJIFILM Sonosite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems?

The FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems 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 FUJIFILM Sonosite, Inc. als Antragsteller

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

Alle 19 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.