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.
Summary
Shantou Institute of Ultrasonic Instruments' Portable DR Imaging System is filed under IZL, mobile x-ray systems. The name is generic, and the record gives no model numbers.
Class II, 21 CFR 892.1720. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
The applicant filed from Shantou, China. The decision came 269 calendar days after receipt (September 22, 2025 to June 18, 2026).
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Product code
- Product 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.