Cleared Special

K161631 - MAMMI

K161631 is an FDA 510(k) clearance for MAMMI, manufactured by General Equipment For Medical Imaging. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 45-day FDA review.

K161631 · General Equipment For Medical Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
45d
Days
Class 2
Risk

K161631 is an FDA 510(k) clearance for the MAMMI. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by General Equipment For Medical Imaging (Valencia, ES). The FDA issued a Cleared decision on July 28, 2016 after a review of 45 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 General Equipment For Medical Imaging devices

FDA 510(k) Submission Details - K161631

510(k) Number K161631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date July 28, 2016
Days to Decision 45 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
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 269
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K161631.
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
K162736 · Siemens Medical Solutions USA, Inc. · Oct 2016
Symbia 6.5
K162337 · Siemens Medical Solutions USA, Inc. · Sep 2016
Discovery MI
K161574 · Ge Medical Systems, LLC · Aug 2016
Discovery NM/CT 670 CZT
K153402 · Ge Healthcare · Jan 2016
Biograph Horizon PET/CT
K152880 · Siemens Medical Solutions USA, Inc. · Jan 2016
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
K151403 · Neusoft Medical Systems Co., Ltd. · Nov 2015