VIVIX-S VW— 510(k) K200418

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K200418 for VIVIX-S VW, Substantially Equivalent on 2020-03-18. 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: 2020-02-20
Decision date: 2020-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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K220239 — Solid State X-ray Imager(Model: FXRD-4386WB)2022-09-13

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