VIVIX-S 4386W (FXRD-4386WA)— 510(k) K260820

Substantially Equivalent

Vieworks 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.

Clearance details

Applicant: Vieworks Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2026-03-13
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.