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Vieworks Secures CE MDR Approval for Next-Generation X-ray Detector Portfolio
2025-12-22
Vieworks Secures CE MDR Approval for
Next-Generation X-ray Detector Portfolio

[Static X-ray detectors, VIVIX-S F Series]
Vieworks, a global provider of medical and industrial imaging solutions, announced on 11/21 that six of its static X-ray detectors - including VIVIX-S F series, VIVIX-S 1751S long-format detectors, and the mid-sized VIVIX-S 4386W - have received CE MDR (Medical Device Regulation) certification from the European Union. Previously, the VIVIX-S V series and the VIVIX-S 1717V also achieved CE MDR certification.
CE MDR is the mandatory regulatory framework for selling medical devices in the EU, and its requirements are significantly stricter than those of the former Medical Devices Directive (MDD).
Vieworks’ detectors met all major criteria, including company-wide quality management processes and post-market surveillance validity, demonstrating compliance with the EU’s highest standards for safety and reliability.
The company’s VIVIX-S F series delivers industry-leading performance with enhanced resolution, durability and user experience. Featuring an ultra-fine 99-micrometer pixel pitch, it maximizes clinical image clarity. The detectors are built with flexible TFT and polyimide substrates, reducing weight by more than 25% while improving impact resistance. Software-based scatter correction further strengthens imaging precision for clinical diagnosis.
*New Medical Imaging (NMI) is the subsidiary of Vieworks, which is the top 3 Flat Panel Detector manufacturer in the global rankings.
If you want to know more Vieworks' X-ray Solution, welcome to contact us👉 sales@newmedical.com.tw