Wireless/ Wired X-Ray Flat Panel Detectors
Allengers Medical Systems LimitedThe Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited are digital imaging devices used with specialized software to capture and process X-ray images of all body parts for general radiographic applications. They convert X-rays into high-quality digital images, aiding radiologists in diagnosis by replacing traditional film-based systems.
Intended Use
Used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR to acquire, process, display, store, and export radiographic images of all body parts using radiographic techniques. Intended for general radiographic applications where film/screener CR systems are used. Not intended for mammography.
Technology
The device consists of wireless and wired digital flat panel detectors with cesium iodide (CsI) scintillators converting X-rays into digital images, paired with AWS software for image acquisition, processing, annotation, and storage on Windows-based computers. It includes features like image compression, memory exposure mode, and water ingress protection. Changes compared to the predicate include modifications in scintillator thickness affecting image quality metrics (DQE, MTF) without impact on performance or safety.
Performance
Non-clinical bench testing and functional tests demonstrated that changes in scintillator thickness result in no safety or effectiveness concerns, maintaining diagnostic image quality equivalent to the predicate device. Tests included EMC emission, ingress protection, and compliance with FDA voluntary standards and guidelines for solid-state X-ray devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/4/2024
4 months - 2
FDA Approval
4/18/2025
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