← Product Code [IZL](/productcode/IZL) · K253058

# Portable DR Imaging System (K253058)

_Shantou Institute of Ultrasonic Instruments Co., Ltd. · IZL · Jun 18, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253058

## Device Facts

- **Applicant:** Shantou Institute of Ultrasonic Instruments Co., Ltd.
- **Product Code:** [IZL](/productcode/IZL.md)
- **Decision Date:** Jun 18, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1720
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K253058](https://fda.innolitics.com/device/K253058)

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