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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 K171734
Device Name HP PRO Positioning Device
Applicant
Orfit Industries NV
9a, Vosveld
Wijnegem,  BE 2110
Applicant Contact Eddy Marivoet
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/12/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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