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510(k) K231157

syngo.CT Lung CAD (Version VD30) by Siemens Healthcare GmbH — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
April 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lung Computed Tomography System, Computer-Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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.

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Other clearances for product code OEB

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  • K221612 — ClearRead CT (December 5, 2022)
  • K203258 — syngo.CT Lung CAD (March 31, 2021)
  • K201501 — Veolity (February 23, 2021)
  • K192880 — InferRead Lung CT.AI (July 2, 2020)
  • K193216 — syngo.CT Lung CAD (March 9, 2020)
  • K161201 — ClearRead CT (September 9, 2016)