# K161631: MAMMI

- Pathway: 510(k) (Special)
- Applicant: General Equipment For Medical Imaging
- Decided: Jul 28, 2016 after 45 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
Longest line of descent: 1 generation back to K140996 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140996: MAMMI, General Equipment For Medical Imaging (Oncovision- (2014) Summary page 4.

## 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/K161631
Methodology: https://510kreport.com/methodology