510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K042694Substantially Equivalent

Advanced Lung Analysis II

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042694 is the FDA 510(k) clearance record for ADVANCED LUNG ANALYSIS II, a class II device, cleared for GE Medical Systems on under FDA product code OEB (Lung Computed Tomography System, Computer-Aided Detection). FDA's definition for product code OEB reads: "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...". FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K042694.

Clearance record

Decision date
Received
(49 days to decision)
Product code
OEB Lung Computed Tomography System, Computer-Aided Detection
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code OEB

Trailing 12 months
2 clearances under product code OEB in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OEB, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260