Cleared Special

K013504 - MODIFICATION TO: ECAT LSO PET/CT SCANNER

K013504 is an FDA 510(k) clearance for MODIFICATION TO: ECAT LSO PET/CT SCANNER, 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 9-day FDA review.

K013504 · Cti Pet Systems, Inc. · Radiology device
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Oct 2001
Decision
9d
Days
Class 2
Risk

K013504 is an FDA 510(k) clearance for the MODIFICATION TO: ECAT LSO PET/CT SCANNER. 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 October 31, 2001 after a review of 9 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 - K013504

510(k) Number K013504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date October 31, 2001
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
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 K013504.
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · Cti Pet Systems, Inc. · Aug 2002
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
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001