510(k) · Radiology

MVision AI Segmentation

by MVision AI

MVision AI Segmentation is an AI-enabled medical device from MVision AI that the U.S. FDA cleared through 510(k) K212915 on May 3, 2022. Its lead review panel is Radiology and its primary product code is QKB (Radiological Image Processing Software For Radiation Therapy).

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

Key facts

Submission numberK212915
Pathway510(k)
Date of final decision
Company (FDA list)MVision AI
Lead review panelRadiology
Primary product codeQKB — Radiological Image Processing Software For Radiation Therapy
Applicant (openFDA)MVision AI
Applicant locationHelsinki, FI
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. MVision AI Segmentation went through this pathway (K212915).

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 QKB covers 46 devices on the FDA AI list. By decision date, this device is #17 of 46 under that code. MVision AI 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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