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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K242488
Device Name Soteria E-View
Applicant
Omega Medical Imaging, LLC
3400 St. Johns Pkwy., Suite 1020
Sanford,  FL  32771
Applicant Contact Matthew Anderson
Correspondent
Omega Medical Imaging, LLC
3400 St. Johns Pkwy., Suite 1020
Sanford,  FL  32771
Correspondent Contact Matthew Anderson
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
QHY  
Date Received08/21/2024
Decision Date 01/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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