Cleared Traditional

K141074 - CORTEX ID SUITE

K141074 is an FDA 510(k) clearance for CORTEX ID SUITE, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K141074 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
146d
Days
Class 2
Risk

K141074 is an FDA 510(k) clearance for the CORTEX ID SUITE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on September 18, 2014 after a review of 146 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.

View all Ge Medical Systems, LLC devices

FDA 510(k) Submission Details - K141074

510(k) Number K141074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2014
Decision Date September 18, 2014
Days to Decision 146 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
39d slower than avg
Panel avg: 107d · This submission: 146d
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 368
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K141074.
Biograph mCT and mCT Flow PET/CT Scanners
K151486 · Siemens Medical Solutions USA, Inc. · Jul 2015
HeartSee
K143664 · University of Texas Medical School AT Houston · Apr 2015
Hermes Medical Imaging Suite v5.5
K142631 · Hermes Medical Solutions AB · Dec 2014
DISCOVERY IQ
K141477 · Ge Medical Systems, LLC · Sep 2014
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
K141971 · Siemens Medical Solutions USA, Inc. · Sep 2014
SYMBIA 6.0
K142006 · Siemens Medical Solutions USA, Inc. · Aug 2014