meddevicedb.com FDA Device Reference

syngo.CT Lung CAD (Version VD30)

K231157 Class II Traditional
Decision Date
2023-07-19
Sponsor / Applicant
Siemens Healthcare GmbH

Technical Specification

510(k) Submission ID K231157
Product Code OEB
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2023-07-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

syngo.CT Lung CAD (Version VD30) received FDA 510(k) clearance under submission number K231157, sponsored by Siemens Healthcare GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-07-19.

Classification & Regulation

This clearance is catalogued under FDA product code OEB and 21 CFR 892.2050, within the Radiology review panel as a Class II device.