Cleared Traditional

K152352 - Stereo 3D option for Vision Applications

K152352 is an FDA 510(k) clearance for Stereo 3D option for Vision Applications, manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152352 · GE Medical Systems SCS · Radiology device
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Jan 2016
Decision
153d
Days
Class 2
Risk

K152352 is an FDA 510(k) clearance for the Stereo 3D option for Vision Applications. 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 GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on January 20, 2016 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. 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 GE Medical Systems SCS devices

FDA 510(k) Submission Details - K152352

510(k) Number K152352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date January 20, 2016
Days to Decision 153 days
Submission Type Traditional
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
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1203
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K152352.
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · Philips Medical Systems Nederland B.V. · Feb 2016
CARESTREAM Vue PACS
K153103 · Carestream Health, Inc. · Feb 2016
Synapse PACS
K160108 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016
Ez3D Plus
K152746 · Ewoosoft Co., Ltd. · Jan 2016
Econsole1
K152172 · DRTECH Corporation · Dec 2015
UroNav (Version 2.0)
K153073 · Invivo Corporation · Nov 2015