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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 K161730
Device Name Wireless Digital Flat Panel Detector
Applicant
IRAY TECHNOLOGY (SHANGHAI) LTD.
ROOM 202, BUILDING 7, NO. 590, RUIQING ROAD
SHANGHAI,  CN 201201
Applicant Contact WEI PAN
Correspondent
IRAY TECHNOLOGY (SHANGHAI) LTD.
ROOM 202, BUILDING 7, NO. 590, RUIQING ROAD
SHANGHAI,  CN 201201
Correspondent Contact WEI PAN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/23/2016
Decision Date 12/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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