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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 K150069
Device Name Fine Structure Analysis(fineSA)
Applicant
Acuitas Medical , Ltd.
12 Technium One, Kings Rd.
Swansea,  GB SA1 8PH
Applicant Contact John Heinrich
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received01/13/2015
Decision Date 05/22/2015
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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