DRX-Revolution Mobile X-ray System
Carestream Health Inc.The DRX-Revolution Mobile X-ray System by Carestream Health is a portable digital X-ray system designed for bedside or mobile use, enabling radiographic examinations of various anatomical regions on pediatric and adult patients. It facilitates image acquisition and processing outside standard stationary X-ray rooms, helping clinicians to obtain high-quality diagnostic images conveniently and efficiently in different clinical settings.
Intended Use
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Technology
The system utilizes digital radiography technology with components including an x-ray generator, tube head assembly (tube and collimator), a maneuverable drive system, touchscreen interface, and ImageView software for image acquisition and processing. It incorporates Smart Noise Cancellation (cleared software feature) to produce high-quality images, compatible with various legally marketed digital flat panel detectors.
Performance
Verification and validation testing of hardware and software confirm safety and performance. Comparative testing demonstrates that Smart Noise Cancellation on the mobile system produces image output equivalent to the in-room system, meeting stringent acceptance criteria for pixel value differences. The device complies with international standards for medical electrical equipment, risk management, usability, and radiation safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/28/2024
6 months - 2
FDA Approval
12/10/2024
Other devices from Carestream Health Inc.
- Eclipse II with Smart Noise Cancellation2022 • 510K
- Eclipse II with Smart Noise Cancellation2021 • 510K
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.