IZL — System, X-Ray, Mobile Class II
FDA Device Classification
Classification Details
- Product Code
- IZL
- Device Class
- Class II
- Regulation Number
- 892.1720
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253185 | carestream health | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | March 11, 2026 |
| K253244 | poskom co | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | February 23, 2026 |
| K250976 | poskom co | Airbile-100 | December 19, 2025 |
| K251710 | solutions for tomorrow | Mobile X-ray unit (!M1) | October 24, 2025 |
| K243864 | bontech co | BONX805 | September 12, 2025 |
| K251443 | drgem corporation | PROMO | August 22, 2025 |
| K251223 | h and abyz co | HnX-P1, HnX-PB | August 4, 2025 |
| K250597 | remedi | REMEX Xcam6 | July 31, 2025 |
| K243473 | prognosys medical systems private limited | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | July 29, 2025 |
| K250750 | dk medical systems co | INNOVISION-P5 | July 18, 2025 |
| K244049 | livermoretech | Europa (Alternative: AiRTouch) portable X-ray system | May 28, 2025 |
| K241980 | solutions for tomorrow | !M1 | May 6, 2025 |
| K241996 | ecoray co | ULTRA 1040 | April 18, 2025 |
| K242015 | drgem corporation | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | December 16, 2024 |
| K241505 | carestream health | DRX-Revolution Mobile X-ray System | December 10, 2024 |
| K240841 | shenzhen browiner tech co | Digital Radiography System (ManntiX B, ManntiX K) | December 9, 2024 |
| K242515 | shanghai united imaging healthcare co | uDR 380i Pro | October 10, 2024 |
| K242651 | samsung electronics co | GM85 | October 1, 2024 |
| K234108 | energy resources international co | ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI P | September 20, 2024 |
| K240009 | first source | iQFlex Pro | July 3, 2024 |