K202353 is an FDA 510(k) clearance for the SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (Shantou, CN). The FDA issued a Cleared decision on December 23, 2020, 127 days after receiving the submission on August 18, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K202353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |