← Product Code [IZL](/productcode/IZL) · K262028

# EUROPA85, EUROPA85L, and EUROPA90 Portable X-ray Systems (EUROPA85, EUROPA85L, EUROPA90) (K262028)

_Aspen Imaging Healthcare, Inc. · IZL · Nov 6, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262028

## Device Facts

- **Applicant:** Aspen Imaging Healthcare, Inc.
- **Product Code:** [IZL](/productcode/IZL.md)
- **Decision Date:** Nov 6, 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/K262028](https://fda.innolitics.com/device/K262028)

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