DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16

System, X-ray, Stationary

VIEWORKS CO., LTD.

The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Digital Radiography System, Model Qxr-16.

Pre-market Notification Details

Device IDK080553
510k NumberK080553
Device Name:DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
ClassificationSystem, X-ray, Stationary
Applicant VIEWORKS CO., LTD. 340 SHADY GROVE ROAD Flintville,  TN  37335
ContactCharlie Mack
CorrespondentMorten S Christensen
UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose,  CA  95131 -1230
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-02-28
Decision Date2008-04-16
Summary:summary

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