510(k) · Radiology

OFIX MIS App

by Orthofix US LLC

OFIX MIS App is an AI-enabled medical device from Orthofix US LLC that the U.S. FDA cleared through 510(k) K230252 on September 26, 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 numberK230252
Pathway510(k)
Date of final decision
Company (FDA list)Orthofix US LLC
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Orthofix US, LLC
Applicant locationLewisville, TX, 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. OFIX MIS App went through this pathway (K230252).

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 #132 of 161 under that code. Orthofix US 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.

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