Cleared Traditional

VIVIX-S 1417N

K163703 · Vieworks Co., Ltd. · Radiology
Feb 2017
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K163703 is an FDA 510(k) clearance for the VIVIX-S 1417N, 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 February 8, 2017, 41 days after receiving the submission on December 29, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K163703 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2016
Decision Date February 08, 2017
Days to Decision 41 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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