510(k) · Radiology

INT Contour

by Carina Medical LLC

INT Contour is an AI-enabled medical device from Carina Medical LLC that the U.S. FDA cleared through 510(k) K212274 on April 8, 2022. Its lead review panel is Radiology and its primary product code is MUJ (System, Planning, Radiation Therapy Treatment).

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

Key facts

Submission numberK212274
Pathway510(k)
Date of final decision
Company (FDA list)Carina Medical LLC
Lead review panelRadiology
Primary product codeMUJ — System, Planning, Radiation Therapy Treatment
Applicant (openFDA)Carina Medical, LLC
Applicant locationLexington, KY, US
Device classClass 2
Regulation number21 CFR 892.5050
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. INT Contour went through this pathway (K212274).

openFDA lists it as a Class 2 device under 21 CFR 892.5050. Class II devices are moderate risk and are subject to general and special controls.

Product code MUJ covers 33 devices on the FDA AI list. By decision date, this device is #14 of 33 under that code. Carina Medical LLC has 1 AI-enabled device 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.

Similar devices (product code MUJ)