Portable DR Imaging System— 510(k) K253058
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd.
FDA 510(k) clearance K253058 for Portable DR Imaging System, Substantially Equivalent on 2026-06-18. Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Recent devices under product code IZL
view allMore clearances from Shantou Institute of Ultrasonic Instruments Co., Ltd.
view allAdverse 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.