syngo.CT Lung CAD— 510(k) K203258

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K203258 for syngo.CT Lung CAD, Substantially Equivalent on 2021-03-31. Applicant: Siemens Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-11-05
Decision date: 2021-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code OEB

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K240554 — InferRead Lung CT.AI2025-05-16
K242919 — V5med Lung AI2025-03-27
K231157 — syngo.CT Lung CAD (Version VD30)2023-07-19

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Data sourced from openFDA. This site is unofficial and independent of the FDA.