15 devices · 12 companies · 2016 to 2026
Product code OWB: Interventional Fluoroscopic X-Ray System
15 devices under product code OWB, 2016 to 2026, from 12 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (15 of 15 here), the regulation, and MAUDE report counts by product code.
Interventional Fluoroscopic X-Ray System. 21 CFR 892.1650, Class II. Interventional fluoroscopy MAUDE held 50,680 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Intelligent NRK252503 · 510(k) | Canon, Inc. | Radiology | database entry | |
| TriniasK252099 · 510(k) | Shimadzu Corporation | Radiology | database entry | |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK253584 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| CARA SystemK252500 · 510(k) | Cara Medical, Ltd. | Radiology | database entry | |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK251602 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| LUMINOS Q.namix TK250660 · 510(k) | Siemens Medical Solutions | Radiology | database entry | |
| TAVIPILOTK243884 · 510(k) | Caranx Medical | Radiology | database entry | |
| uAngio AVIVA CXK243376 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | database entry | |
| 3DXRK243446 · 510(k) | GE Medical Systems SCS | Radiology | database entry | |
| O-arm O2 Imaging SystemK240465 · 510(k) | Medtronic Navigation, Inc | Radiology | database entry | |
| EndoNautK222070 · 510(k) | Therenva SAS | Radiology | database entry | |
| Cydar EVK212442 · 510(k) | Cydar Ltd. | Radiology | database entry | |
| Soteria.AIK212336 · 510(k) | Omega Medical Imaging, LLC | Radiology | database entry | |
| EndoNautK212383 · 510(k) | Therenva SAS | Radiology | database entry | |
| Cydar EVK160088 · 510(k) | Cydar Ltd. | Radiology | database entry |
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