K242488
- 510(k) number
- K242488
- Device name
- Soteria E-View
- Applicant
- Omega Medical Imaging, LLC FL · US
- Product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Decision date
- 2025-01-06
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242488.pdf
Official FDA record: K242488
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.