Wireless/Wired X-Ray Flat Panel Detectors— 510(k) K223009

Name: FDA 510(k) clearance K223009
Creator: U.S. Food and Drug Administration
Published: 2022-11-27

Substantially Equivalent

Allengers Medical Systems Limited

FDA 510(k) clearance K223009 for Wireless/Wired X-Ray Flat Panel Detectors, Substantially Equivalent on 2022-11-27. Applicant: Allengers Medical Systems Limited. Device class: 2.

Clearance details

Applicant: Allengers Medical Systems Limited
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-09-29
Decision date: 2022-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derabassi, Distt. Mohali, IN

Download summary PDF View on FDA.gov ↗

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