SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

System, X-ray, Mobile

Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI)

The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Sr-2300 Portable Dr Imaging System, Sr-2300s Portable Dr Imaging System.

Pre-market Notification Details

Device IDK202353
510k NumberK202353
Device Name:SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
ClassificationSystem, X-ray, Mobile
Applicant Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
ContactFlower Cai
CorrespondentFlower Cai
Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
Product CodeIZL  
Subsequent Product CodeLLZ
Subsequent Product CodeMQB
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-18
Decision Date2020-12-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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06938396423018 K202353 000
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06938396423018 K202353 000
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06938396423018 K202353 000
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06938396423018 K202353 000
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06938396423025 K202353 000
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06938396423025 K202353 000
06938396423018 K202353 000
06938396423018 K202353 000

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