Cleared Traditional

K914267 - GE 4096 PLUS & GE 2048

K914267 is an FDA 510(k) clearance for GE 4096 PLUS & GE 2048, 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 297-day FDA review.

K914267 · GE Medical Systems · Radiology device
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Jul 1992
Decision
297d
Days
Class 2
Risk

K914267 is an FDA 510(k) clearance for the GE 4096 PLUS & GE 2048. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 16, 1992 after a review of 297 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K914267

510(k) Number K914267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date July 16, 1992
Days to Decision 297 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
190d slower than avg
Panel avg: 107d · This submission: 297d
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 K914267.
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM
K922373 · Siemens Gammasonics, Inc. · Aug 1992
CARDIAC FIRST PASS ANALYSIS
K921777 · GE Medical Systems · Aug 1992
GENESYS II
K922080 · Adac Laboratories · Jul 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · General Electric Co. · Apr 1992
APEX HELIX - A
K914807 · Elscint, Inc. · Feb 1992
CEQUAL(TM)
K914527 · General Electric Co. · Nov 1991