Wireless/ Wired X-Ray Flat Panel Detectors— 510(k) K243734

Name: FDA 510(k) clearance K243734
Creator: U.S. Food and Drug Administration
Published: 2025-04-18

Substantially Equivalent

Allengers Medical Systems Limited

FDA 510(k) clearance K243734 for Wireless/ Wired X-Ray Flat Panel Detectors, Substantially Equivalent on 2025-04-18. 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: 2024-12-04
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sas Nagar Mohali, IN

Download summary PDF View on FDA.gov ↗

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K200218 — Digiscan FDX2020-07-13

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