Cleared Traditional

VIVIX-S 1751S

K190611 · Vieworks Co., Ltd. · Radiology
Apr 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K190611 is an FDA 510(k) clearance for the VIVIX-S 1751S, 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 April 8, 2019, 28 days after receiving the submission on March 11, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K190611 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2019
Decision Date April 08, 2019
Days to Decision 28 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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