510(k) K042694

ADVANCED LUNG ANALYSIS II by GE Medical Systems — Product Code OEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 18, 2004
Date Received: September 30, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

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 GE Medical Systems

K253780 — SIGNA Bolt (February 6, 2026)
K253779 — SIGNA Sprint Select (February 5, 2026)
K252379 — AIR Recon DL (December 23, 2025)
K251399 — SIGNA Sprint (September 11, 2025)
K250941 — Revolution Vibe (August 1, 2025)
K243667 — Sonic DL (June 5, 2025)
K250379 — SIGNA Prime Elite (March 17, 2025)
K241242 — SIGNA MAGNUS (October 17, 2024)
K233750 — ECG-less Cardiac (April 2, 2024)
K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suit (May 25, 2023)

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)
K201501 — Veolity (February 23, 2021)
K192880 — InferRead Lung CT.AI (July 2, 2020)
K193216 — syngo.CT Lung CAD (March 9, 2020)