Cleared Traditional

ADVANCED LUNG ANALYSIS II

K042694 · GE Medical Systems · Radiology

Nov 2004

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K042694 is an FDA 510(k) clearance for the ADVANCED LUNG ANALYSIS II, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on November 18, 2004, 49 days after receiving the submission on September 30, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K042694 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2004
Decision Date	November 18, 2004
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	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.