# K111731: Molecular Breast Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Gamma Medica-Ideas Incorporated
- Decided: Sep 15, 2011 after 87 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K892358 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002782: Hermes HD AQ Acquisition Station and Hermes Workstation, Nuclear Diagnostics AB (2000) Summary page 1.
- K010726: Modification to Mirage, Segami Corp., Inc. (2001)
- K080961: NM Application Suite, Philips Nuclear Medicine, Inc. (2008) Summary page 1.

## Indications for use
The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEMT gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.

Source page: https://510kreport.com/device/K111731
Methodology: https://510kreport.com/methodology