IZL — System, X-Ray, Mobile Class II
FDA product code IZL covers "System, X-Ray, Mobile", a Class II medical device regulated under 21 CFR 892.1720. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253058 | shantou institute of ultrasonic instruments co | Portable DR Imaging System | June 18, 2026 |
| K260085 | drgem corporation | RAYMO Mobile X-ray System (Model: RAYMO) | May 14, 2026 |
| 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 |