# K140996: MAMMI

- Pathway: 510(k) (Traditional)
- Applicant: General Equipment For Medical Imaging (Oncovision-
- Decided: Jun 11, 2014 after 55 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161631: MAMMI (2016), 0 descendants of its own

## Indications for use
MAMMI (Models: FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.

Source page: https://510kreport.com/device/K140996
Methodology: https://510kreport.com/methodology