Cleared Traditional

K920624 - ECAT EXACT HR MODEL 961

K920624 is an FDA 510(k) clearance for ECAT EXACT HR MODEL 961, manufactured by Cti Pet Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K920624 · Cti Pet Systems, Inc. · Radiology device
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Apr 1992
Decision
76d
Days
Class 2
Risk

K920624 is an FDA 510(k) clearance for the ECAT EXACT HR MODEL 961. 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 April 27, 1992 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cti Pet Systems, Inc. devices

FDA 510(k) Submission Details - K920624

510(k) Number K920624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date April 27, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K920624.
CARDIAC FIRST PASS ANALYSIS
K921777 · GE Medical Systems · Aug 1992
GENESYS II
K922080 · Adac Laboratories · Jul 1992
GE 4096 PLUS & GE 2048
K914267 · GE Medical Systems · Jul 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · General Electric Co. · Apr 1992
APEX HELIX - A
K914807 · Elscint, Inc. · Feb 1992
ECAT SCANNER (MODEL 921)
K913637 · Cti Pet Systems, Inc. · Nov 1991