510(k) · Radiology

syngo.CT Lung CAD

by Siemens Healthcare GmbH

syngo.CT Lung CAD is an AI-enabled medical device from Siemens Healthcare GmbH that the U.S. FDA cleared through 510(k) K203258 on March 31, 2021. Its lead review panel is Radiology and its primary product code is OEB (Lung Computed Tomography System, Computer-Aided Detection).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK203258
Pathway510(k)
Date of final decision
Company (FDA list)Siemens Healthcare GmbH
Lead review panelRadiology
Primary product codeOEB — Lung Computed Tomography System, Computer-Aided Detection
Applicant (openFDA)Siemens Healthcare GmbH
Applicant locationForchheim, DE
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. syngo.CT Lung CAD went through this pathway (K203258).

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 OEB covers 10 devices on the FDA AI list. By decision date, this device is #4 of 10 under that code. Siemens Healthcare GmbH has 15 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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