X-ray Flat Panel Detectors (EverestView 4343X)— 510(k) K223687

Name: FDA 510(k) clearance K223687
Creator: U.S. Food and Drug Administration
Published: 2022-12-30

Substantially Equivalent

Careray Digital Medical Technology Co., Ltd.

FDA 510(k) clearance K223687 for X-ray Flat Panel Detectors (EverestView 4343X), Substantially Equivalent on 2022-12-30. Applicant: Careray Digital Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Careray Digital Medical Technology Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-12-09
Decision date: 2022-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.