SR-1000 Portable DR Imaging System, SR-1000S 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-1000 Portable Dr Imaging System, Sr-1000s Portable Dr Imaging System.

Pre-market Notification Details

Device IDK202350
510k NumberK202350
Device Name:SR-1000 Portable DR Imaging System, SR-1000S 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 Date2021-01-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938396410063 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410063 K202350 000
06938396410049 K202350 000
06938396410049 K202350 000

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