EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
DRTECH CorporationThe EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.
Intended Use
EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. It is intended for both adult and pediatric populations and not intended for mammography applications.
Technology
The device is a flat-panel digital X-ray detector using indirect conversion technology, where incoming X-rays are converted to visible light via a scintillator, then into electrical charges via an optical sensor and thin film transistors, finally converted to digital images. It differs from traditional X-ray film by capturing images electronically and transmitting them via standard communication interfaces, integrated with diagnostic X-ray systems.
Performance
Performance testing including bench tests for DQE and MTF showed values comparable or slightly differing but equivalent to the predicate device. Firmware validation and cybersecurity testing were performed in compliance with FDA guidance. Clinical image quality was confirmed equivalent to predicate devices through a qualified expert concurrence study across various body parts.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/13/2024
6 months - 2
FDA Approval
3/20/2025
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