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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 K183713
Device Name Wireless Digital Flat Detector
Applicant
iRay Technology Taicang Ltd.
No. 33 Xinggang Rd., Taicang Port Economic &
Technological Development Zone
Taicang,  CN 215434
Applicant Contact Meng Li
Correspondent
iRay Technology Taicang Ltd.
No. 33 Xinggang Rd., Taicang Port Economic &
Technological Development Zone
Taicang,  CN 215434
Correspondent Contact Meng Li
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/10/2018
Decision Date 01/09/2019
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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