Cleared Traditional

VIVIX-S WIRELESS

K122865 · Vieworks Co., Ltd. · Radiology
Feb 2013
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K122865 is an FDA 510(k) clearance for the VIVIX-S WIRELESS, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Vieworks Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on February 1, 2013, 136 days after receiving the submission on September 18, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K122865 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2012
Decision Date February 01, 2013
Days to Decision 136 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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