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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 K161625
Device Name PixelShine
Applicant
Algomedica
2600 El Camino Real, Suite 100
Palo Alto,  CA  94306
Applicant Contact Jagdish Vij
Correspondent
Devine Guidance International, Inc.
4730 S. Fort Apache Rd., Suite 300
Las Vegas,  NV  89147
Correspondent Contact Christopher J. Devine
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/13/2016
Decision Date 09/19/2016
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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