3 devices · 1 company · 2019 to 2025
Omega Medical Imaging, LLC: AI-enabled devices on FDA's list
3 devices from Omega Medical Imaging, LLC, 2019 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Omega Medical Imaging, LLC
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Soteria E-ViewK242488 · 510(k) | Radiology | JAA | database entry | |
| Soteria.AIK212336 · 510(k) | Radiology | OWB | database entry | |
| CS-series-FP Radiographic / Fluoroscopic SystemsK191713 · 510(k) | Radiology | JAA | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.