Cleared Traditional

K955185 - GE ADVANTAGE DICOM CR REPROCESSING STATION

K955185 is an FDA 510(k) clearance for GE ADVANTAGE DICOM CR REPROCESSING STATION, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K955185 · GE Medical Systems · Radiology device
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Jan 1996
Decision
51d
Days
Class 2
Risk

K955185 is an FDA 510(k) clearance for the GE ADVANTAGE DICOM CR REPROCESSING STATION. 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 (Waukesha, US). The FDA issued a Cleared decision on January 3, 1996 after a review of 51 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. 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 devices

FDA 510(k) Submission Details - K955185

510(k) Number K955185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date January 03, 1996
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 K955185.
PHILIPS EASYVISION
K953911 · Philips Medical Systems, Inc. · Jun 1996
DIGISCAN 2 PLUS
K955457 · Siemens Medical Solutions USA, Inc. · Jun 1996
GE ADVANTAGE WINDOWS REVIEW WORKSTATION
K960613 · GE Medical Systems · Apr 1996
ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM
K944612 · Codman & Shurtleff, Inc. · Dec 1995
VOXELVIEW
K953259 · Vital Images, Inc. · Nov 1995
HP ECHO IMAGE MANAGEMENT SYSTEM
K954668 · Hewlett-Packard Co. · Nov 1995