Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)— 510(k) K221512

Name: FDA 510(k) clearance K221512
Creator: U.S. Food and Drug Administration
Published: 2022-07-20

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K221512 for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW), Substantially Equivalent on 2022-07-20. 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: 2022-05-24
Decision date: 2022-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, 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.