Cleared Traditional

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

K221512 · Vieworks Co., Ltd. · Radiology
Jul 2022
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K221512 is an FDA 510(k) clearance for the Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW), a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on July 20, 2022, 57 days after receiving the submission on May 24, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K221512 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2022
Decision Date July 20, 2022
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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