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510(k) K201501

Veolity by Mevis Medical Solutions AG — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2021
Date Received
June 5, 2020
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.

Other clearances by Mevis Medical Solutions AG

  • K232045 — MeVis Liver Suite (October 27, 2023)
  • K120207 — VISIA (April 23, 2012)
  • K120484 — VISIA ONCOLOGY (March 27, 2012)
  • K113701 — VISIA NEURO (February 16, 2012)
  • K113337 — VISIA DYNAMIC REVIEW (December 30, 2011)

Other clearances for product code OEB

  • K251203 — AVIEW Lung Nodule CAD (December 3, 2025)
  • K240554 — InferRead Lung CT.AI (May 16, 2025)
  • K242919 — V5med Lung AI (March 27, 2025)
  • K231157 — syngo.CT Lung CAD (Version VD30) (July 19, 2023)
  • K221592 — AVIEW Lung Nodule CAD (February 24, 2023)
  • K221612 — ClearRead CT (December 5, 2022)
  • K203258 — syngo.CT Lung CAD (March 31, 2021)
  • K192880 — InferRead Lung CT.AI (July 2, 2020)
  • K193216 — syngo.CT Lung CAD (March 9, 2020)
  • K161201 — ClearRead CT (September 9, 2016)