FDA 510(k)

SonoBook Series Diagnostic Ultrasound System

K-Nummer: K170374 · 2017-06-06

AntragstellerChison Medical Imaging Co., Ltd.

Entscheidungsdatum2017-06-06

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

SonoBook Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Chison Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170374. 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 SonoBook Series Diagnostic Ultrasound System?

SonoBook Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Chison Medical Imaging Co., Ltd.. The 510(k) number is K170374.

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

SonoBook Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170374.

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

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

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

The FDA product code for SonoBook 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 Chison Medical Imaging Co., Ltd. als Antragsteller

K170870Site~Rite Halcyon Diagnostic Ultrasound System K162172EBit Series Diagnostic Ultrasound System

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.