# K061255: Brainacquirerx / Brainprocessrx Data Suite Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Kyron Clinical Imaging, Inc.
- Decided: Jun 13, 2006 after 40 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: 2 generations back to K003899 (2001). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023130: Eloquence, Integrated Functional Imaging System, Mri Devices Corp. (2002) Summary page 1.
- K043290: Mindstate Functional Data Acquisition Device, Version 1.0, Neurognostics, Inc. (2005) Summary page 1.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.
- K003573: Diffusion Tensor Imaging Option, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K082964: Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5) (2009), 1 descendant of its own
- K122026: Prism Acquire Prism Process Prism View (2012), 0 descendants of its own

## Indications for use
The BrainAcquireRx / BrainProcessRx Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRD and other MRI data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Source page: https://510kreport.com/device/K061255
Methodology: https://510kreport.com/methodology