GeneralDevice clearance

FDA Clears Vieworks VIVIX-S 4386W Digital Radiography Detector

FDA 510(k) — Radiology devices2w ago

FDA 510(k) cleared the VIVIX-S 4386W (FXRD-4386WA), a solid-state digital X-ray detector from Vieworks Co., Ltd. (product code MQB). Intended for general radiographic imaging.

  • Device classified under FDA product code MQB (solid-state X-ray imager, flat panel digital).
  • No performance data or clinical validation details were provided in the clearance announcement.
  • This summary is based on limited public information; full device specifications are not included.
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