510(k) · Radiology

LVivo IQS

by DiA Imaging Analysis Ltd.

LVivo IQS is an AI-enabled medical device from DiA Imaging Analysis Ltd. that the U.S. FDA cleared through 510(k) K240769 on May 24, 2024. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK240769
Pathway510(k)
Date of final decision
Company (FDA list)DiA Imaging Analysis Ltd.
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Dia Imaging Analysis, Ltd.
Applicant locationBeer-Sheva, IL
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. LVivo IQS went through this pathway (K240769).

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 QIH covers 305 devices on the FDA AI list. By decision date, this device is #119 of 305 under that code. DiA Imaging Analysis Ltd. has 10 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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