# K073167: Brainstat Software Option for GE Signa MR Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jan 4, 2008 after 56 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911667 (1991). 37 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera, Esaote, S.p.A. (2006) Summary page 1.

## Most influential descendants
- K080762: IB Neuro, Version 1.0 (2008), 5 descendants of its own
- K123302: IB Clinic (2013), 1 descendant of its own
- K120637: Synapse 3D Brain Perfusion (2012), 1 descendant of its own
- K211356: GIQuant (2021), 0 descendants of its own
- K162287: Synapse 3D Perfusion Analysis (2017), 0 descendants of its own

## Indications for use
BrainStat is an automated post-processing software option that is designed to process a time-series of MR images acquired in the brain. BrainStat is indicated for use on dynamic magnetic resonance imaging data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the integrated-area of the signal intensity change, the time from the beginning of the change of intensity to the end of the intensity change, and the ratio of the integrated area to the time. BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K073167
Methodology: https://510kreport.com/methodology