IZL
- Product code
- IZL
- Device name
- System, X-Ray, Mobile
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1720
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 25
- Summaries archived here
- 23 (direct download)
- 510(k) clearances (all years, FDA)
- 237 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (25)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260236 | 2026-08-03 | GEMSS HEALTHCARE CO., LTD. | XLITE | FDA |
| K253058 | 2026-06-18 | Shantou Institute of Ultrasonic Instru… | Portable DR Imaging System | |
| K260085 | 2026-05-14 | DRGEM Corporation | RAYMO Mobile X-ray System (Model: RAYMO) | |
| K253185 | 2026-03-11 | Carestream Health | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mo… | |
| K253244 | 2026-02-23 | Poskom Co., Ltd. | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, A… | |
| K250976 | 2025-12-19 | Poskom Co., Ltd. | Airbile-100 | |
| K251710 | 2025-10-24 | Solutions For Tomorrow AB | Mobile X-ray unit (!M1) | |
| K243864 | 2025-09-12 | Bontech Co., Ltd. | BONX805 | |
| K251443 | 2025-08-22 | DRGEM Corporation | PROMO | |
| K251223 | 2025-08-04 | H&abyz Co., Ltd. | HnX-P1, HnX-PB | |
| K250597 | 2025-07-31 | Remedi, Inc. | REMEX Xcam6 | |
| K243473 | 2025-07-29 | Prognosys Medical Systems Private Limi… | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTAB… | |
| K250750 | 2025-07-18 | Dk Medical Systems Co., Ltd. | INNOVISION-P5 | |
| K244049 | 2025-05-28 | Livermoretech, Inc. | Europa (Alternative: AiRTouch) portable X-ray system | |
| K241980 | 2025-05-06 | Solutions For Tomorrow AB | !M1 | |
| K241996 | 2025-04-18 | Ecoray Co., Ltd. | ULTRA 1040 | |
| K242015 | 2024-12-16 | DRGEM Corporation | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ… | |
| K241505 | 2024-12-10 | Carestream Health, Inc. | DRX-Revolution Mobile X-ray System | |
| K240841 | 2024-12-09 | Shenzhen Browiner Tech Co., Ltd. | Digital Radiography System (ManntiX B, ManntiX K) | |
| K242515 | 2024-10-10 | Shanghai United Imaging Healthcare Co.… | uDR 380i Pro | |
| K242651 | 2024-10-01 | Samsung Electronics Co., Ltd. | GM85 | |
| K234108 | 2024-09-20 | Energy Resources International Co., Lt… | ERI Portable X-ray System (CVX-air); ERI Portable X-… | |
| K240009 | 2024-07-03 | First Source, Inc. | iQFlex Pro | |
| K240284 | 2024-03-28 | Shenzhen Browiner Tech Co., Ltd. | Digital Radiography System (MobileApex 60E, MobileAp… | |
| K233678 | 2024-02-14 | Philips Medical Systems Dmc GmbH | Radiography 7000 M | FDA |
Official FDA classification page: IZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).