AIBOLIT 3D+

System, Image Processing, Radiological

AIbolit Technologies, LLC

The following data is part of a premarket notification filed by Aibolit Technologies, Llc with the FDA for Aibolit 3d+.

Pre-market Notification Details

Device IDK211443
510k NumberK211443
Device Name:AIBOLIT 3D+
ClassificationSystem, Image Processing, Radiological
Applicant AIbolit Technologies, LLC 9616 Moritz Way Delray Beach,  FL  33446
ContactHoward Schrayer
CorrespondentHoward Schrayer
AIbolit Technologies, LLC 9616 Moritz Way Delray Beach,  FL  33446
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2022-01-07

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