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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 K160284
Device Name JointPoint
Applicant
Jointpoint, Inc.
402 Buttonwood Ln.
Largo,  FL  33770
Applicant Contact Noah D. Wollowick
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
HAW  
Date Received02/03/2016
Decision Date 08/03/2016
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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