Cleared Traditional

VIVIX-S 1717V

K181003 · Vieworks Co., Ltd. · Radiology
May 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K181003 is an FDA 510(k) clearance for the VIVIX-S 1717V, 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 May 15, 2018, 29 days after receiving the submission on April 16, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K181003 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2018
Decision Date May 15, 2018
Days to Decision 29 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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