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.
| Device ID | K202353 |
| 510k Number | K202353 |
| Device Name: | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System |
| Classification | System, X-ray, Mobile |
| Applicant | Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou, CN 515041 |
| Contact | Flower Cai |
| Correspondent | Flower Cai Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou, CN 515041 |
| Product Code | IZL |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-18 |
| Decision Date | 2020-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396423025 | K202353 | 000 |
| 06938396423018 | K202353 | 000 |
| 06938396400446 | K202353 | 000 |
| 06938396400439 | K202353 | 000 |
| 06938396400767 | K202353 | 000 |