Product code IZL
- Device name
- System, X-Ray, Mobile
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1720
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | 2026-05-14 |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | 2026-03-11 |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | 2026-02-23 |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 2025-12-19 |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025-10-24 |
| K243864 | BONX805 | Bontech Co., Ltd. | 2025-09-12 |
| K251443 | PROMO | DRGEM Corporation | 2025-08-22 |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 2025-08-04 |
| K250597 | REMEX Xcam6 | Remedi, Inc. | 2025-07-31 |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | 2025-07-29 |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025-07-18 |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025-05-28 |
| K241980 | !M1 | Solutions For Tomorrow AB | 2025-05-06 |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | 2025-04-18 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024-12-16 |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024-12-10 |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | 2024-10-01 |
| 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. | 2024-09-20 |
| K240009 | iQFlex Pro | First Source, Inc. | 2024-07-03 |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. | 2024-03-28 |
| K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024-02-14 |
| K232185 | SM-IV | Sedecal., Sa. | 2023-08-21 |
| K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | 2023-08-16 |
| K231577 | MOBILETT Impact | Siemens Medical Solutions | 2023-07-25 |
| K222896 | AirRay | Poskom Co., Ltd. | 2022-12-20 |
| K222951 | SM-V | Sedecal., Sa. | 2022-11-21 |
| K222258 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 |
| K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436046002463 | SEDECAL | SEDECAL | 2019-11-30 |
| 08436046002449 | SEDECAL | SEDECAL | 2019-11-30 |
| 08436046002432 | SEDECAL | SEDECAL | 2019-11-30 |
| 08436046002487 | SEDECAL | SEDECAL | 2019-11-15 |
| 08436046002364 | SEDECAL | SEDECAL | 2019-10-04 |
| 08436046002357 | Philips | SEDECAL | 2019-08-09 |
| 08436046001893 | SEDECAL | SEDECAL | 2018-02-15 |
| 08436046001886 | SEDECAL | SEDECAL | 2018-02-15 |
| 08436046002173 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002166 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001879 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001862 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001831 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001855 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001848 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001091 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001824 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001794 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001787 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001770 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001602 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001596 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001589 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001572 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001510 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001503 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001497 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001466 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001121 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001114 | SEDECAL | SEDECAL | 2016-10-28 |