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);
DRTECH CorporationThe EXSYS DEXi is a stationary X-ray system designed for generating radiographic images of human anatomy for general diagnostic purposes. It functions by acquiring images through radiation exposure and processing these images at a workstation to provide anatomical information. This system supports clinicians in diagnosing a wide range of conditions by delivering high-quality digital radiographs, and it is not intended for mammography.
Intended Use
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose.
Technology
The device consists of an X-ray generator, tube, collimator, tube stand, bucky stand, patient table, flat panel detector, and a console, and operates by exposing patients to X-ray radiation and processing the images digitally on a workstation. It includes enhancements over the predicate device, such as added collimators, mechanical parts, detectors, and upgraded software.
Performance
The device has undergone non-clinical performance testing according to various international and FDA-recognized standards including IEC 60601, ISO 14971, IEC 62304, and UL ANSI 2900-1. Tests showed no negative impact on safety or efficacy compared to the predicate, with no new potential or increased safety risks. Clinical studies were deemed unnecessary.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/20/2024
1 month - 2
FDA Approval
10/23/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.