# K111791: Lumagem Molecular Breast Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Gamma Medica-Ideas Incorporated
- Decided: Sep 23, 2011 after 88 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952674 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993813: Lumagem Scintillation Camera, Gamma Medica (2000) Summary page 1.
- K102231: Discovery NM 750B, Ge Medical Systems Israel, Functional Imaging (2010) Summary page 1.

## Most influential descendants
- K123408: Ergo Imaging System (2013), 0 descendants of its own

## Indications for use
The LumaGEM Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM TM Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 key for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.

Source page: https://510kreport.com/device/K111791
Methodology: https://510kreport.com/methodology