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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K201043
Device Name Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
Applicant
Iray Technology Taicang , Ltd.
#33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang,  CN 215434
Applicant Contact Junjie Qian
Correspondent
Iray Technology Taicang , Ltd.
#33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang,  CN 215434
Correspondent Contact Junjie Qian
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/20/2020
Decision Date 05/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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