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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 K150976
Device Name Collage
Applicant
Anatomage, Inc.
111n. Market St., #500
San Jose,  CA  95113
Applicant Contact SEAN XU
Correspondent
Anatomage, Inc.
111n. Market St., #500
San Jose,  CA  95113
Correspondent Contact SEAN XU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/13/2015
Decision Date 06/04/2015
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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