SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System— 510(k) K202353
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA 510(k) clearance K202353 for SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System, Substantially Equivalent on 2020-12-23. Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.