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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 K210312
Device Name PlutoX Digital Intraoral X-Ray Imaging System
Applicant
Iray Technology Taicang , Ltd.
#33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang,  CN 215434
Applicant Contact Wei Pan
Correspondent
Iray Technology Taicang , Ltd.
#33 Xinggang Rd., Taicang Port Economic & Technological
Development Zone
Taicang,  CN 215434
Correspondent Contact Wei Pan
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/03/2021
Decision Date 04/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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