K242488 is an FDA 510(k) clearance for the Soteria E-View. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on January 6, 2025, 138 days after receiving the submission on August 21, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K242488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2024 |
| Decision Date | January 06, 2025 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA - System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |