Cleared Traditional

VIVIX-S 1012N

K152855 · Vieworks Co., Ltd. · Radiology
Feb 2016
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K152855 is an FDA 510(k) clearance for the VIVIX-S 1012N, 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 26, 2016, 150 days after receiving the submission on September 29, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K152855 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2015
Decision Date February 26, 2016
Days to Decision 150 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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