Portable DR Imaging System
Device Facts
| Record ID | K253058 |
|---|---|
| Device Name | Portable DR Imaging System |
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd. |
| Product Code | IZL · Radiology |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
