Cleared Special

K022872 - GE ROAD WARRIOR PET CT IMAGING SYSTEM

K022872 is the FDA 510(k) clearance for GE ROAD WARRIOR PET CT IMAGING SYSTEM by General Electric Co.. It is a Class 2 Radiology device (product code KPS) cleared through the Special 510(k) pathway after a 14-day FDA review.

K022872 · General Electric Co. · Radiology device
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Sep 2002
Decision
14d
Days
Class 2
Risk

K022872 is an FDA 510(k) clearance for the GE ROAD WARRIOR PET CT IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on September 12, 2002 after a review of 14 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 General Electric Co. devices

Submission Details

510(k) Number K022872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2002
Decision Date September 12, 2002
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K022872.
SKYLIGHT IMAGING SYSTEM
K031705 · Adac Laboratories · Jun 2003
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K030199 · General Electric Co. · Feb 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003
MOBILE MILLENNIUM MG SYSTEM
K022240 · Ge Medical Systems, Inc. · Aug 2002
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · Adac Laboratories · Nov 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · GE Medical Systems · Sep 2001