Cleared Special

K113350 - BRIVO NM 615

K113350 is an FDA 510(k) clearance for BRIVO NM 615, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 21-day FDA review.

K113350 · Ge Healthcare · Radiology device
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Dec 2011
Decision
21d
Days
Class 2
Risk

K113350 is an FDA 510(k) clearance for the BRIVO NM 615. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 5, 2011 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare devices

FDA 510(k) Submission Details - K113350

510(k) Number K113350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date December 05, 2011
Days to Decision 21 days
Submission Type Special
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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 376
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K113350.
Q. FREEZE (MOTION VUE2)
K113408 · Ge Medical Systems, LLC · Feb 2012
ACQA
K113086 · Texas Medical Imaging Consultants · Jan 2012
BIOGRAPH MCT FAMILY
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CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
K112474 · Cedars-Sinai Medical Center · Sep 2011
CARDIAC SCANNER AND PROCESSING SYSTEM
K110507 · Spectrum Dynamics (Israel) , Ltd. · Jul 2011
DISCOVERY NM 630
K111445 · Ge Healthcare · Jun 2011