510(k) K242919

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

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

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)
K161201 — ClearRead CT (September 9, 2016)