Cleared Special

K030199 - GE MOBILE DISCOVERY ST PET CT IMAGING S...

K030199 is the FDA 510(k) clearance for GE MOBILE DISCOVERY ST PET CT IMAGING S... by General Electric Co.. It is a Class 2 Radiology device (product code KPS) cleared through the Special 510(k) pathway after a 21-day FDA review.

K030199 · General Electric Co. · Radiology device
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Feb 2003
Decision
21d
Days
Class 2
Risk

K030199 is an FDA 510(k) clearance for the GE MOBILE DISCOVERY ST 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 February 11, 2003 after a review of 21 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 K030199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date February 11, 2003
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 K030199.
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc. · Jul 2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
K031872 · Adac Laboratories · Jun 2003
SKYLIGHT IMAGING SYSTEM
K031705 · Adac Laboratories · Jun 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · Ge Medical Systems, Inc. · Aug 2002