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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
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