Cleared Special

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ (K033431) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033431 · Cti Pet Systems, Inc. · Radiology device
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Nov 2003
Decision
23d
Days
Class 2
Risk

K033431 is an FDA 510(k) clearance for the LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ. 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 20, 2003 after a review of 23 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

Submission Details

510(k) Number K033431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2003
Decision Date November 20, 2003
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
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 172
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K033431.
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc. · Jul 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co. · Feb 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003