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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K210682
Device Name SOTA Cloud Imaging
Applicant
Sota Precision Optics, Inc. Dba Sota Imaging
1073 N. Batavia St., Suite B
Orange,  CA  90404
Applicant Contact Edward Johansen
Correspondent
Sota Precision Optics, Inc. Dba Sota Imaging
1073 N. Batavia St., Suite B
Orange,  CA  90404
Correspondent Contact Edward Johansen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/2021
Decision Date 05/04/2021
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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