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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 K230059
Device Name Digital Flat Panel Detector
Applicant
Ray Imaging Technology (Haining) Limited
No. 2, Caohejing RD., Haining 314499, Jiaxing
Haining,  CN 314499
Applicant Contact Jeffrey Wu
Correspondent
Ray Imaging Technology (Haining) Limited
No. 2, Caohejing RD., Haining 314499, Jiaxing
Haining,  CN 314499
Correspondent Contact Jeffrey Wu
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/09/2023
Decision Date 02/03/2023
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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