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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K160723
Device Name OnSight 3D Extremity System
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Applicant Contact Carolyn Wagner
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Carolyn Wagner
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/16/2016
Decision Date 08/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT02445287
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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