Cleared Traditional

syngo.CT Lung CAD (Version VD30)

K231157 · Siemens Healthcare GmbH · Radiology

Jul 2023

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K231157 is an FDA 510(k) clearance for the syngo.CT Lung CAD (Version VD30), 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 July 19, 2023, 86 days after receiving the submission on April 24, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K231157 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2023
Decision Date	July 19, 2023
Days to Decision	86 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.