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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.
No. 33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang,  CN 215434
Applicant Contact Junjie Qian
Correspondent
iRay Technology Taicang Ltd.
No. 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
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