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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 K230998
Device Name Digital Wireless Intraoral X-Ray Sensor
Applicant
Iray Imaging Technology (Haining) Limited
3rd Floor, Bldg. 1, # 2, Caohejing Rd.
Haining,  CN 314499
Applicant Contact Junjie Qian
Correspondent
Iray Imaging Technology (Haining) Limited
3rd Floor, Bldg. 1, # 2, Caohejing Rd.
Haining,  CN 314499
Correspondent Contact Junjie Qian
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/07/2023
Decision Date 10/20/2023
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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