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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K212336
Device Name Soteria.AI
Applicant
Omega Medical Imaging, LLC
3400 St. Johns Pkwy., Suite 1020
Sanford,  FL  32771
Applicant Contact John Newman
Correspondent
Omega Medical Imaging, LLC
3400 St. Johns Pkwy., Suite 1020
Sanford,  FL  32771
Correspondent Contact John Newman
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/27/2021
Decision Date 11/17/2021
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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