(196 days)
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.
The provided text describes a 510(k) premarket notification for the DRX-Revolution Mobile X-ray System, which includes changes such as the addition of Smart Noise Cancellation (SNC) functionality and compatibility with a new detector (Lux 35). The study focuses on demonstrating the substantial equivalence of the modified device to a previously cleared predicate device (DRX-Revolution Mobile X-ray System, K191025).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for SNC) | Reported Device Performance |
|---|---|
| At least 99% of all image pixels were within ± 1 pixel value | Achieved. The results demonstrated that at least 99% of all image pixels were within ± 1 pixel value. |
| Absolute maximum difference across all test images should be ≤ 10-pixel values | Achieved. The absolute maximum difference seen across all test images was 3-pixel values, meeting the acceptance criterion of a maximum allowable difference of 10-pixel values. |
| Noise ratio values computed for every pixel of the test images should be |
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.