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.
RadPigeon summaries are original and for information only. They are not clinical advice.