Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1720](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1720) → IZL — System, X-Ray, Mobile

# IZL · System, X-Ray, Mobile

_Radiology · 21 CFR 892.1720 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL

## Overview

- **Product Code:** IZL
- **Device Name:** System, X-Ray, Mobile
- **Regulation:** [21 CFR 892.1720](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1720)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (20 of 234)

Showing 20 most recent of 234 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253185](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K253185.md) | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | Mar 11, 2026 | SESE |
| [K253244](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K253244.md) | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | Feb 23, 2026 | SESE |
| [K250976](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K250976.md) | Airbile-100 | Poskom Co., Ltd. | Dec 19, 2025 | SESE |
| [K251710](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K251710.md) | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | Oct 24, 2025 | SESE |
| [K243864](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K243864.md) | BONX805 | Bontech Co., Ltd. | Sep 12, 2025 | SESE |
| [K251443](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K251443.md) | PROMO | DRGEM Corporation | Aug 22, 2025 | SESE |
| [K251223](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K251223.md) | HnX-P1, HnX-PB | H&abyz Co., Ltd. | Aug 4, 2025 | SESE |
| [K250597](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K250597.md) | REMEX Xcam6 | Remedi, Inc. | Jul 31, 2025 | SESE |
| [K243473](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K243473.md) | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | Jul 29, 2025 | SESE |
| [K250750](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K250750.md) | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | Jul 18, 2025 | SESE |
| [K244049](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K244049.md) | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | May 28, 2025 | SESE |
| [K241980](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K241980.md) | !M1 | Solutions For Tomorrow AB | May 6, 2025 | SESE |
| [K241996](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K241996.md) | ULTRA 1040 | Ecoray Co., Ltd. | Apr 18, 2025 | SESE |
| [K242015](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K242015.md) | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | Dec 16, 2024 | SESE |
| [K241505](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K241505.md) | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | Dec 10, 2024 | SESE |
| [K240841](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K240841.md) | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | Dec 9, 2024 | SESE |
| [K242515](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K242515.md) | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | Oct 10, 2024 | SESE |
| [K242651](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K242651.md) | GM85 | Samsung Electronics Co., Ltd. | Oct 1, 2024 | SESE |
| [K234108](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K234108.md) | ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) | Energy Resources International Co., Ltd. | Sep 20, 2024 | SESE |
| [K240009](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K240009.md) | iQFlex Pro | First Source, Inc. | Jul 3, 2024 | SESE |

## Top Applicants

- Sedecal., Sa. — 17 clearances
- Minxray, Inc. — 15 clearances
- General X-Ray, Inc. — 11 clearances
- Samsung Electronics Co., Ltd. — 8 clearances
- Source-Ray, Inc. — 6 clearances

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL)

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