Cleared Traditional

syngo.CT Lung CAD

K203258 · Siemens Healthcare GmbH · Radiology

Mar 2021

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K203258 is an FDA 510(k) clearance for the syngo.CT Lung CAD, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on March 31, 2021, 146 days after receiving the submission on November 5, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K203258 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class	Class II — 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.