Cleared Traditional

K964012 - GENIE PROCESSING AND REVIEW WORKSTATION

K964012 is an FDA 510(k) clearance for GENIE PROCESSING AND REVIEW WORKSTATION, 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 92-day FDA review.

K964012 · GE Medical Systems · Radiology device
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Jan 1997
Decision
92d
Days
Class 2
Risk

K964012 is an FDA 510(k) clearance for the GENIE PROCESSING AND REVIEW WORKSTATION. 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 January 7, 1997 after a review of 92 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K964012

510(k) Number K964012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date January 07, 1997
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
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 K964012.
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
PRISM XPVT SYSTEM (210823)
K964712 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · Elscint, Inc. · Jan 1997
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · Toshiba Medical Systems · Dec 1996
QUANTEM
K963162 · Elscint, Inc. · Nov 1996
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
K962738 · GE Medical Systems · Oct 1996