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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 K213529
Device Name Focus HD 43 Detector
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 Received11/04/2021
Decision Date 03/29/2022
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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