Cleared Special

K012568 - GE VISION NUCLEAR MEDICINE WORKSTATION

K012568 is the FDA 510(k) clearance for GE VISION NUCLEAR MEDICINE WORKSTATION by General Electric Co.. It is a Class 2 Radiology device (product code KPS) cleared through the Special 510(k) pathway after a 28-day FDA review.

K012568 · General Electric Co. · Radiology device
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Sep 2001
Decision
28d
Days
Class 2
Risk

K012568 is an FDA 510(k) clearance for the GE VISION NUCLEAR MEDICINE WORKSTATION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by General Electric Co. (Twinsburg, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 28 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 K012568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date September 06, 2001
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 K012568.
MOBILE MILLENNIUM MG SYSTEM
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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
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001
GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc. · Dec 2000
ALLEGRO TB, ALLEGRO N
K003434 · Adac Laboratories · Nov 2000