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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K230811
Device Name Digital Intraoral X-Ray Sensor
Applicant
Iray Imaging Technology (Haining) Limited
# 2, Caohejing Rd., Haining 314499, Jiaxing
Zhejiang, P.R.China
Haining,  CN 314499
Applicant Contact Jeffrey Wu
Correspondent
Iray Imaging Technology (Haining) Limited
# 2, Caohejing Rd., Haining 314499, Jiaxing
Zhejiang, P.R.China
Haining,  CN 314499
Correspondent Contact Jeffrey Wu
Regulation Number872.1800
Classification Product Code
MUH  
Date Received03/24/2023
Decision Date 04/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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