# K022240: Mobile Millennium MG System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 6, 2002 after 26 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: 2 generations back to K915470 (1992). 6 ancestors in all.
11 later devices descend from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962738: Millennium MT and Millennium MG Nuclear Medicine Systems, GE Medical Systems (1996) Summary page 1.
- K000395: Einstein Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2000) Summary page 1.

## Most influential descendants
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K213649: BodyTom 64 (2022), 2 descendants of its own
- K131431: Airo CT System (2013), 2 descendants of its own

## Indications for use
The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multi-slice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.

Source page: https://510kreport.com/device/K022240
Methodology: https://510kreport.com/methodology