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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, Mobile
510(k) Number K202353
Device Name SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
Applicant
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
77 Jinsha Rd.
Shantou,  CN 515041
Applicant Contact Flower Cai
Correspondent
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
77 Jinsha Rd.
Shantou,  CN 515041
Correspondent Contact Flower Cai
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Codes
LLZ   MQB  
Date Received08/18/2020
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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