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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 K151438
Device Name Dentrix Ascend Imaging
Applicant
REALCLOUD IMAGING INC.
2060 ALAMEDA PADRE SERRA, SUITE 100
santa barbara,  CA  93013
Applicant Contact douglas a. golay
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact mark job
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/29/2015
Decision Date 07/07/2015
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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