Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)— 510(k) K201043

Name: FDA 510(k) clearance K201043
Creator: U.S. Food and Drug Administration
Published: 2020-05-12

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K201043 for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W), Substantially Equivalent on 2020-05-12. 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: 2020-04-20
Decision date: 2020-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Taicang, 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.