Cleared Traditional

DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9

K073056 · Vieworks Co., Ltd. · Radiology
Nov 2007
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K073056 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Vieworks Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 13, 2007, 14 days after receiving the submission on October 30, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K073056 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2007
Decision Date November 13, 2007
Days to Decision 14 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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