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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 K210314
Device Name Mars1717X Wireless Digital Flat Panel 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 Received02/03/2021
Decision Date 03/02/2021
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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