IZL · System, X-Ray, Mobile
Radiology · 21 CFR 892.1720 · Class 2
Overview
| Product Code | IZL |
|---|---|
| Device Name | System, X-Ray, Mobile |
| Regulation | 21 CFR 892.1720 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 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 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | Mar 11, 2026 | SESE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | Feb 23, 2026 | SESE |
| K250976 | Airbile-100 | Poskom Co., Ltd. | Dec 19, 2025 | SESE |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | Oct 24, 2025 | SESE |
| K243864 | BONX805 | Bontech Co., Ltd. | Sep 12, 2025 | SESE |
| K251443 | PROMO | DRGEM Corporation | Aug 22, 2025 | SESE |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | Aug 4, 2025 | SESE |
| K250597 | REMEX Xcam6 | Remedi, Inc. | Jul 31, 2025 | SESE |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | Jul 29, 2025 | SESE |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | Jul 18, 2025 | SESE |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | May 28, 2025 | SESE |
| K241980 | !M1 | Solutions For Tomorrow AB | May 6, 2025 | SESE |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | Apr 18, 2025 | SESE |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | Dec 16, 2024 | SESE |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | Dec 10, 2024 | SESE |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | Dec 9, 2024 | SESE |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | Oct 10, 2024 | SESE |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | Oct 1, 2024 | SESE |
| K234108 | 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 | 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
