Cleared Traditional

K923309 - ARGUS PET SYSTEM

K923309 is an FDA 510(k) clearance for ARGUS PET SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K923309 · GE Medical Systems · Radiology device
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Sep 1992
Decision
84d
Days
Class 2
Risk

K923309 is an FDA 510(k) clearance for the ARGUS PET SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on September 29, 1992 after a review of 84 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.

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FDA 510(k) Submission Details - K923309

510(k) Number K923309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date September 29, 1992
Days to Decision 84 days
Submission Type Traditional
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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 250
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K923309.
CORT-EX
K926133 · General Electric Co. · Jun 1993
OPTITRACK
K924877 · Adac Laboratories · Dec 1992
MAXXUS
K924498 · GE Medical Systems · Dec 1992
MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM
K922372 · Siemens Gammasonics, Inc. · Aug 1992
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM
K922373 · Siemens Gammasonics, Inc. · Aug 1992
CARDIAC FIRST PASS ANALYSIS
K921777 · GE Medical Systems · Aug 1992