Cleared Special

MODIFICARION TO WACKERS-LIU CQ SOFTWARE (K032500) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032500 · Eclipse Systems, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
12d
Days
Class 2
Risk

K032500 is an FDA 510(k) clearance for the MODIFICARION TO WACKERS-LIU CQ SOFTWARE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Eclipse Systems, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 25, 2003 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eclipse Systems, Inc. devices

Submission Details

510(k) Number K032500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2003
Decision Date August 25, 2003
Days to Decision 12 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 172
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K032500.
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc. · Jul 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co. · Feb 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003