Cleared Special

K023518 - ECAT LSO PET/CT 16

K023518 is an FDA 510(k) clearance for ECAT LSO PET/CT 16, manufactured by Cti Pet Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 18-day FDA review.

K023518 · Cti Pet Systems, Inc. · Radiology device
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Nov 2002
Decision
18d
Days
Class 2
Risk

K023518 is an FDA 510(k) clearance for the ECAT LSO PET/CT 16. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cti Pet Systems, Inc. (Knoxville, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 18 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 Cti Pet Systems, Inc. devices

FDA 510(k) Submission Details - K023518

510(k) Number K023518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date November 08, 2002
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K023518.
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · Ge Medical Systems F.I. Haifa · Dec 2002
ECAT PET/CT
K023768 · Cti Pet Systems, Inc. · Nov 2002
GE QUASAR NUCLEAR MEDICINE SYSTEM
K022960 · Ge Medical Systems F.I. Haifa · Sep 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · Cti Pet Systems, Inc. · Aug 2002