Cleared Special

K063006 - GE LOGIQ WORKS

K063006 is an FDA 510(k) clearance for GE LOGIQ WORKS, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 31-day FDA review.

K063006 · General Electric Co. · Radiology device
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Nov 2006
Decision
31d
Days
Class 2
Risk

K063006 is an FDA 510(k) clearance for the GE LOGIQ WORKS. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all General Electric Co. devices

FDA 510(k) Submission Details - K063006

510(k) Number K063006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date November 02, 2006
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1896
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063006.
ISITE PACS, V 4. X
K063267 · Stentor Inc., A Philips Medical Systems Co. · Nov 2006
XERON PACS
K062757 · Xeron Healthcare Corp. · Nov 2006
SECTRA WORKSTATION, VERSION 11.1
K063093 · Sectra-Imtec AB · Nov 2006
PRISM VIEW, MODEL
K063031 · Kyron Clinical Imaging, Inc. · Nov 2006
IMT.LAB SOFTWARE
K062598 · Esaote Europe B.V. · Oct 2006
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
K062743 · Electronic Business Machine Co., Ltd. (Ebm) · Oct 2006