Soteria E-View
FDA 510(k) K242488 · Omega Medical Imaging, LLC
510(k) numberK242488
Submission
- Device name
- Soteria E-View
- Applicant
- Omega Medical Imaging, LLC
Sanford, FL, US - Received
- August 21, 2024
- Decision date
- January 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Soteria E-View cleared by the FDA?
Soteria E-View (K242488) received a 510(k) decision of Substantially Equivalent on January 6, 2025, 138 days after the submission was received.
What is the product code of K242488?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.