Cleared Special

Wireless/ Wired X-Ray Flat Panel Detectors

K243734 · Allengers Medical Systems Limited · Radiology
Apr 2025
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K243734 is an FDA 510(k) clearance for the Wireless/ Wired X-Ray Flat Panel Detectors, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Allengers Medical Systems Limited (Sas Nagar Mohali, IN). The FDA issued a Cleared decision on April 18, 2025, 135 days after receiving the submission on December 4, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K243734 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2024
Decision Date April 18, 2025
Days to Decision 135 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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