Wireless Digital Flat Detector— 510(k) K183713

Name: FDA 510(k) clearance K183713
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K183713 for Wireless Digital Flat Detector, Substantially Equivalent on 2019-01-09. Applicant: Iray Technology Taicang , Ltd.. Device class: 2.

Clearance details

Applicant: Iray Technology Taicang , Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2018-12-10
Decision date: 2019-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Taicang, CN

Download summary PDF View on FDA.gov ↗

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