510(k) · Radiology

Biograph Vision.X and Biograph Vision.X Edge

by Siemens Medical Solutions USA, Inc.

Biograph Vision.X and Biograph Vision.X Edge is an AI-enabled medical device from Siemens Medical Solutions USA, Inc. that the U.S. FDA cleared through 510(k) K231833 on July 13, 2023. Its lead review panel is Radiology and its primary product code is KPS (System, Tomography, Computed, Emission).

See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.

Key facts

Submission numberK231833
Pathway510(k)
Date of final decision
Company (FDA list)Siemens Medical Solutions USA, Inc.
Lead review panelRadiology
Primary product codeKPS — System, Tomography, Computed, Emission
Applicant (openFDA)Siemens Medical Solutions USA, Inc.
Applicant locationHoffman Estates, IL, US
Device classClass 2
Regulation number21 CFR 892.1200
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. Biograph Vision.X and Biograph Vision.X Edge went through this pathway (K231833).

openFDA lists it as a Class 2 device under 21 CFR 892.1200. Class II devices are moderate risk and are subject to general and special controls.

Product code KPS covers 26 devices on the FDA AI list. By decision date, this device is #12 of 26 under that code. Siemens Medical Solutions USA, Inc. has 67 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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