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510(k) K240554

InferRead Lung CT.AI by Infervision Medical Technology Co., Ltd. — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
February 28, 2024
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 Infervision Medical Technology Co., Ltd.

  • K211179 — InferRead CT Stroke.AI (August 12, 2021)

Other clearances for product code OEB

  • K251203 — AVIEW Lung Nodule CAD (December 3, 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)
  • 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)