Cleared Traditional

K140996 - MAMMI

K140996 is an FDA 510(k) clearance for MAMMI, manufactured by General Equipment For Medical Imaging (Oncovision-. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K140996 · General Equipment For Medical Imaging (Oncovision- · Radiology device
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Jun 2014
Decision
55d
Days
Class 2
Risk

K140996 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 (Oncovision- (Valencia, ES). The FDA issued a Cleared decision on June 11, 2014 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Equipment For Medical Imaging (Oncovision- devices

FDA 510(k) Submission Details - K140996

510(k) Number K140996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date June 11, 2014
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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
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