EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
DRTECH CorporationThe EXPD-N series by DRTECH Corporation is a digital flat panel X-ray detector designed for use in digital radiography. It replaces traditional film or screen-based X-ray systems and aids clinicians by providing high-quality digital images for general diagnostic imaging of human anatomy in both adults and children. It supports improved imaging performance and faster image acquisition for better diagnosis.
Intended Use
The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography.
Technology
The EXPD-N series detector is a square plate-shaped indirect conversion device that converts incoming X-rays into visible light, which is then captured by an optical sensor to produce an electrical charge. This charge is read through thin-film transistors, amplified, and converted from analog to digital form for image production. The device uses a flexible amorphous silicon TFT material deposited on a plastic substrate instead of glass, with options for different pixel pitches (100μm and 140μm) impacting resolution and sensitivity.
Performance
Non-clinical performance testing included major physical metrics such as modulation transfer function (MTF) and detective quantum efficiency (DQE) compared with a predicate device, demonstrating comparable imaging performance. Clinical images from various anatomical sites were reviewed by expert clinicians confirming diagnostic suitability. Electrical safety and electromagnetic compatibility tests met IEC standards. Clinical studies were not required due to equivalency with the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/6/2024
4 months - 2
FDA Approval
3/19/2025
Other devices from DRTECH Corporation
- EXTRON 3; EXTRON 5; EXTRON 72025 • 510K
- EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2025 • 510K
- EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);2024 • 510K
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