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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K151137
Device Name X-VIEW, IMAGEN
Applicant
Edlen Imaging, LLC
16441 N 91st St. Suite 102
Scottsdale,  AZ  85260
Applicant Contact NICK RADACHI
Correspondent
Edlen Imaging, LLC
16441 N 91st St. Suite 102
Scottsdale,  AZ  85260
Correspondent Contact NICK RADACHI
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received04/29/2015
Decision Date 06/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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