OWB — Interventional Fluoroscopic X-Ray System Class II
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 |
|---|---|---|---|
| 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 |
| K251602 | canon medical systems corporation | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | October 10, 2025 |
| K251523 | siemens medical solutions usa | Cios Spin | July 29, 2025 |
| K243432 | brainlab | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | July 22, 2025 |
| K250660 | siemens medical solutions | LUMINOS Q.namix T; LUMINOS Q.namix R | July 14, 2025 |
| K251520 | siemens medical solutions usa | Cios Alpha; Cios Flow | July 9, 2025 |
| K243884 | caranx medical | TAVIPILOT | July 7, 2025 |
| K250010 | drtech corporation | EXTRON 3; EXTRON 5; EXTRON 7 | June 10, 2025 |
| K243411 | nanjing perlove medical equipment co | Diagnostic X-ray System | May 19, 2025 |
| K242731 | medicatech usa | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | May 16, 2025 |
| K250282 | a.t.s. applicazione tecnologie speciali | Persona C HR | April 30, 2025 |
| K243376 | shanghai united imaging healthcare co | uAngio AVIVA CX | April 28, 2025 |