Cleared Special

K033431 - LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

K033431 is an FDA 510(k) clearance for LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ, 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 23-day FDA review.

K033431 · Cti Pet Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033431

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
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 K033431.
MYOLIGHT
K033874 · Ge Medical Systems F.I. Haifa · Dec 2003
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
K033735 · Adac Laboratories · Dec 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · Adac Laboratories · Oct 2003
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