# K080762: IB Neuro, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Biometrics, LLC
- Decided: May 15, 2008 after 58 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: 10 generations back to K911667 (1991). 38 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K073167: Brainstat Software Option for GE Signa MR Scanner, Ge Medical Systems, LLC (2008) Summary page 2.
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera, Esaote, S.p.A. (2006) Summary page 2.
- K984224: Perfusion Package for Magnetom Vision and Symphony Systems, Siemens Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K091444: Perfscape (2009), 0 descendants of its own

## Indications for use
IB Neuro TM software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. lB NeuroTM vi.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may yield information useful in clinical applications. Our advanced technology is designed to be compliant with healthcare standards such as DICOM and is easily and rapidly integrated into existing medical image visualization applications.

Source page: https://510kreport.com/device/K080762
Methodology: https://510kreport.com/methodology