510(k) · Radiology

Limbus Contour

by Limbus AI Inc.

Limbus Contour is an AI-enabled medical device from Limbus AI Inc. that the U.S. FDA cleared through 510(k) K230575 on April 7, 2023. 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 2023, all FDA AI clearances in 2023, top radiology AI devices.

Key facts

Submission numberK230575
Pathway510(k)
Date of final decision
Company (FDA list)Limbus AI Inc.
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Limbus Ai, Inc.
Applicant locationRegina, CA
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeSpecial

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. Limbus Contour went through this pathway (K230575).

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 #122 of 161 under that code. Limbus AI Inc. has 3 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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