Last synced on 17 May 2024 at 11:06 pm

Soteria.AI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212336
510(k) Type
Traditional
Applicant
Omega Medical Imaging, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/2021
Days to Decision
113 days
Submission Type
Summary

Soteria.AI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212336
510(k) Type
Traditional
Applicant
Omega Medical Imaging, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/2021
Days to Decision
113 days
Submission Type
Summary