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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 K211443
Device Name AIBOLIT 3D+
Applicant
AIbolit Technologies, LLC
9616 Moritz Way
Delray Beach,  FL  33446
Applicant Contact Howard Schrayer
Correspondent
AIbolit Technologies, LLC
9616 Moritz Way
Delray Beach,  FL  33446
Correspondent Contact Howard Schrayer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/10/2021
Decision Date 01/07/2022
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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