510(k) · Radiology

AIBOLIT 3D+

by AIbolit Technologies, LLC

AIBOLIT 3D+ is an AI-enabled medical device from AIbolit Technologies, LLC that the U.S. FDA cleared through 510(k) K211443 on January 7, 2022. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK211443
Pathway510(k)
Date of final decision
Company (FDA list)AIbolit Technologies, LLC
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Aibolit Technologies, LLC
Applicant locationDelray Beach, FL, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AIBOLIT 3D+ went through this pathway (K211443).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #105 of 161 under that code. AIbolit Technologies, LLC has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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