# K113408: Q. Freeze (Motion VUE2)

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Feb 24, 2012 after 98 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: 6 generations back to K010641 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081496: Optima Pet/CT 560, Ge Medical Systems, LLC (2008) Summary page 2.

## Most influential descendants
- K210418: HYPER Focus (2021), 0 descendants of its own

## Indications for use
MotionVUE2 (Q.freeze) is a PET/CT, non- invasive image analysis software application* designed to support the viewing and manipulation of medical images from PET and CT imaging modalities. MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multi-planar volumes and cine loops. MotionVUE2 (Q.freeze) allows the users to generate from their 4D-PET or 4D-PET/CT series a registered 4D-PET series used for quantification of lesions and analysis of functional activity. With MotionVUE2 (Q.freeze), users will have the possibility to compare static PET/CT, 4D3-PET/CT, and registered 4DPET series including visual comparison, quantification of lesions, and analysis of functional activity. MotionVUJE2 (Q.freeze) providesregistration performance of up to 2mnu of center of mass motion when motion is no larger than the diameter of the object. N'otionVUE2 (Q.freeze) provides comparable/equivalent improvement of quantification results (SUV and size) as 4D PET techniques- MotionVUE2 (Q.freeze) can be used for features with locally concentrated activity within the entire Thorax area- This area includes the organs where PET/CT imaging has the most challenges due to respiatry motion: Lung, Liver, Pancreas.

Source page: https://510kreport.com/device/K113408
Methodology: https://510kreport.com/methodology