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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 K191158
Device Name The AIO Solution
Applicant
Orfit Industries NV
9A, Vosveld
Wijnegem,  BE 2110
Applicant Contact Eddy Marivoet
Correspondent
Arazy Group Consultants Inc.
68 Southwood Terrace
Southbury,  CT  06488
Correspondent Contact Ray Kelly
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/01/2019
Decision Date 08/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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