VIVIX-S 4386W (FXRD-4386WA)— 510(k) K260820
Substantially EquivalentVieworks Co., Ltd.
FDA 510(k) clearance K260820 for VIVIX-S 4386W (FXRD-4386WA), Substantially Equivalent on 2026-06-18. Applicant: Vieworks Co., Ltd.. Device class: 2.
Summary
Vieworks' VIVIX-S 4386W (FXRD-4386WA) is filed under MQB, solid state x-ray imagers (flat panel or digital imagers). The record doesn't describe the imager beyond the model numbers and the code name.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Vieworks filed from Gyeonggi-Do, South Korea. Review took 97 calendar days (March 13 to June 18, 2026).
Clearance details
- Applicant
- Vieworks Co., Ltd.
- Product code
- Product code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gyeonggi-Do, KR
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