Mars 1417X Wireless Digital Flat Panel Detector— 510(k) K210316

Name: FDA 510(k) clearance K210316
Creator: U.S. Food and Drug Administration
Published: 2021-03-03

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K210316 for Mars 1417X Wireless Digital Flat Panel Detector, Substantially Equivalent on 2021-03-03. 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: 2021-02-03
Decision date: 2021-03-03
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.