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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 K202068
Device Name The AIO Solution 3.0
Applicant
Orfit Industries NV
9a, Vosveld
Wijnegem,  BE 2110
Applicant Contact Eddy Marivoet
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Ln
New Smyrna Beach,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/27/2020
Decision Date 08/14/2020
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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