Vieworks Obtains CE MDR Certification for Additional Static X-ray Detectors
2026-05-14
Vieworks, a leading provider of medical imaging solutions, has obtained CE MDR (Medical Device Regulation) certification for five models in its VIVIX-S series of static X-ray detectors.
The newly certified products are four models in the VIVIX-S VR series and the VIVIX-S 4386W. CE MDR meets stricter requirements than the previous Medical Device Directive, particularly on product safety, clinical evidence and post-market surveillance.
The VIVIX-S VR series has a 99-micrometer pixel pitch for high-resolution imaging and is configurable for a range of clinical environments. The VIVIX-S 4386W offers a wide detection area, capturing whole-spine and long-bone images in a single exposure.
Vieworks completed the review process in three months. The company demonstrated that the products under review were substantially equivalent to previously certified products in design, intended use and technical characteristics, and grouped them under the same Basic UDI-DI.
Basic UDI-DI is the identifier used under MDR to group device families. When products qualify as a single group, the scope of Notified Body review can be adjusted accordingly. Vieworks established its Basic UDI-DI grouping strategy at the outset of its MDR transition to reduce the clinical evaluation and technical documentation burden.
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Vieworks' X-ray Imaging Solutions
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