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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 K171130
Device Name Nucleus Image Management System
Applicant
NucleusHealth, LLC
13280 Evening Creek Dr.
san diego,  CA  91928
Applicant Contact linda moore
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25TH STREET, NW
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/17/2017
Decision Date 05/04/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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