CareView 1800Cw X-ray Flat Panel Detectors— 510(k) K172581

Name: FDA 510(k) clearance K172581
Creator: U.S. Food and Drug Administration
Published: 2017-09-26

Substantially Equivalent

Careray Digital Medical System Co., Ltd.

FDA 510(k) clearance K172581 for CareView 1800Cw X-ray Flat Panel Detectors, Substantially Equivalent on 2017-09-26. Applicant: Careray Digital Medical System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Careray Digital Medical System Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-08-28
Decision date: 2017-09-26
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.