OWB — Interventional Fluoroscopic X-Ray System Class II
FDA product code OWB covers "Interventional Fluoroscopic X-Ray System", a Class II medical device regulated under 21 CFR 892.1650. 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
- OWB
- Device Class
- Class II
- Regulation Number
- 892.1650
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
Interventional fluoroscopy
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253726 | shanghai united imaging healthcare co | uAngio AVIVA CX | August 21, 2026 |
| K261413 | drtech corporation | EXTRON 3;EXTRON 6 | August 19, 2026 |
| K254205 | philips medical systems nederland | Zenition 30 | August 7, 2026 |
| K260607 | radiaction | Shield System (Siemens 30x40) | July 31, 2026 |
| K253670 | philips medical systems | SmartCT (R3.0 (L10)) | July 10, 2026 |
| K252735 | pulmera | C-beam | May 22, 2026 |
| K252503 | canon | Intelligent NR | April 30, 2026 |
| K254173 | siemens medical solutions usa | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | April 24, 2026 |
| K253752 | siemens medical solutions usa | ARTIS genio floor; ARTIS icono.explore floor | April 23, 2026 |
| K252229 | genoray co | BELLIGER ACE | April 2, 2026 |
| K252099 | shimadzu corporation | Trinias | March 24, 2026 |
| K253584 | canon medical systems corporation | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | March 10, 2026 |
| K252500 | cara medical | CARA System | February 20, 2026 |
| K251992 | savfe co. | ArmSure Fluoroscopic Positioning System | February 11, 2026 |
| K254186 | philips medical systems | Azurion R3.1 | January 16, 2026 |
| K252068 | oxos medical | MC2 Portable X-ray System | December 22, 2025 |
| K251893 | skanray technologies limited | SKAN C PULSAR | December 16, 2025 |
| K251199 | ge medical systems scs | Allia Moveo | December 9, 2025 |
| K250241 | siemens medical solutions usa | Cios Select | November 4, 2025 |
| K251827 | philips medical systems | Azurion R3.1 | October 24, 2025 |