Cleared Special

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I (K050509) - FDA 510(k) Clearance

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

K050509 · Cti Pet Systems, Inc. · Radiology device
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Mar 2005
Decision
24d
Days
Class 2
Risk

K050509 is an FDA 510(k) clearance for the LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I. 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 March 25, 2005 after a review of 24 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 K050509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date March 25, 2005
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 K050509.
GEMINI RAPTOR
K052640 · Philips Medical Systems (Cleveland), Inc. · Oct 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · GE Medical Systems · Sep 2005
GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc. · May 2005
GE DISCOVERY VCT SYSTEM
K050559 · GE Medical Systems · Mar 2005
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004
C-PET PLUS IMAGING SYSTEM
K042839 · Philips Medical Systems (Cleveland), Inc. · Oct 2004