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510(k) K242919

V5med Lung AI by V5med, Inc. — Product Code OEB

K242919 is an FDA 510(k) premarket notification submitted by V5med, Inc. for the device "V5med Lung AI". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code OEB (Lung Computed Tomography System, Computer-Aided Detection), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2025
Date Received
September 24, 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 for product code OEB

  • K254075 — Synapse Lung Nodule AI (May 27, 2026)
  • K251203 — AVIEW Lung Nodule CAD (December 3, 2025)
  • K240554 — InferRead Lung CT.AI (May 16, 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)

FDA data resources