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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, x-ray, extraoral with timer
510(k) Number K223010
Device Name Portable X-ray System
Applicant
iRay Technology Taicang Ltd.
No.33 Xinggang Rd.,
Taicang Port Economic & Technological Development Zone
Taicang,  CN 215434
Applicant Contact Wei Pan
Correspondent
iRay Technology Taicang Ltd.
No.33 Xinggang Rd.,
Taicang Port Economic & Technological Development Zone
Taicang,  CN 215434
Correspondent Contact Wei Pan
Regulation Number872.1800
Classification Product Code
EHD  
Date Received09/29/2022
Decision Date 01/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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