K260820
- 510(k) number
- K260820
- Device name
- VIVIX-S 4386W (FXRD-4386WA)
- Applicant
- Vieworks Co., Ltd. KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2026-06-18
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260820.pdf
Official FDA record: K260820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.