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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K162002
Device Name Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
Applicant
Zdi, Solutions, LLC
800 S Gay St., Suite 714
Knoxville,  TN  37909
Applicant Contact Zachary A. Dutton
Correspondent
Zdi, Solutions, LLC
800 S Gay St., Suite 714
Knoxville,  TN  37909
Correspondent Contact Zachary A. Dutton
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/20/2016
Decision Date 11/01/2016
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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