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FDA 510(k)

Wireless/ Wired X-Ray Flat Panel Detectors

K-Number: K243734 · 2025-04-18

ApplicantAllengers Medical Systems Limited
Decision Date2025-04-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless/ Wired X-Ray Flat Panel Detectors is a medical device manufactured by Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2025-04-18 under approval number K243734. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless/ Wired X-Ray Flat Panel Detectors?

Wireless/ Wired X-Ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by Allengers Medical Systems Limited. The 510(k) number is K243734.

When was Wireless/ Wired X-Ray Flat Panel Detectors approved by the FDA?

Wireless/ Wired X-Ray Flat Panel Detectors received FDA 510(k) clearance on 2025-04-18, under approval number K243734.

What company makes Wireless/ Wired X-Ray Flat Panel Detectors?

Wireless/ Wired X-Ray Flat Panel Detectors is manufactured by Allengers Medical Systems Limited.

What is the FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors is MQB.

Related Clinical Trials

NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Allengers Medical Systems Limited

K162529DigiX FDX K192541DigiX FDX K200218Digiscan FDX K223009Wireless/Wired X-Ray Flat Panel Detectors K223060DigiX FDX K220311Cardiovascular Angiography System

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Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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