510(k) K243734

Wireless/ Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited — Product Code MQB

K243734 is an FDA 510(k) premarket notification submitted by Allengers Medical Systems Limited for the device "Wireless/ Wired X-Ray Flat Panel Detectors". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Allengers Medical Systems Limited has at least 7 other 510(k) clearances on record.