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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K222458
Device Name AIBOLIT 3D+
Applicant
Aibolit Technologies, LLC
9616 Moritz Way
Delray Beach,  FL  33446
Applicant Contact Gregory Piskun
Correspondent
Howard Schrayer
8 Lookout
Hilton Head Island,  SC  29928
Correspondent Contact Howard Schrayer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/15/2022
Decision Date 01/12/2023
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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