Cleared Traditional

Wireless/Wired X-Ray Flat Panel Detectors

K223009 · Allengers Medical Systems Limited · Radiology
Nov 2022
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K223009 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 (Derabassi, Distt. Mohali, IN). The FDA issued a Cleared decision on November 27, 2022, 59 days after receiving the submission on September 29, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K223009 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date November 27, 2022
Days to Decision 59 days
Submission Type Traditional
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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