4 devices · 3 companies · 2018 to 2025
Product code JAA: System, X-Ray, Fluoroscopic, Image-Intensified
4 devices under product code JAA, 2018 to 2025, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
System, X-Ray, Fluoroscopic, Image-Intensified. 21 CFR 892.1650, Class II. MAUDE held 90,614 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 |
|---|---|---|---|---|
| Soteria E-ViewK242488 · 510(k) | Omega Medical Imaging, LLC | Radiology | database entry | |
| XIDF-AWS801, Angio WorkstationK232526 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| CS-series-FP Radiographic / Fluoroscopic SystemsK191713 · 510(k) | Omega Medical Imaging, LLC | Radiology | database entry | |
| DR 800 with MUSICA DynamicK180589 · 510(k) | Agfa HealthCare N.V. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.