Cleared Traditional

K203258 - syngo.CT Lung CAD (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203258 · Siemens Healthcare GmbH · Radiology device
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Mar 2021
Decision
146d
Days
Class 2
Risk

K203258 is an FDA 510(k) clearance for the syngo.CT Lung CAD. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on March 31, 2021 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare GmbH devices

Submission Details

510(k) Number K203258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2020
Decision Date March 31, 2021
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OEB Lung Computed Tomography System, Computer-aided Detection

All 18
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K203258.
AVIEW Lung Nodule CAD
K251203 · Coreline Soft Co., Ltd. · Dec 2025
InferRead Lung CT.AI
K240554 · Infervision Medical Technology Co., Ltd. · May 2025
V5med Lung AI
K242919 · V5med, Inc. · Mar 2025
syngo.CT Lung CAD (Version VD30)
K231157 · Siemens Healthcare GmbH · Jul 2023
AVIEW Lung Nodule CAD
K221592 · Coreline Soft Co., Ltd. · Feb 2023