# K043290: Mindstate Functional Data Acquisition Device, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Neurognostics, Inc.
- Decided: Jan 28, 2005 after 60 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073099: Fmri Hardware System (2007), 7 descendants of its own
- K080515: Fmri Hardware System (2008), 5 descendants of its own
- K092253: Modification to Fmri Hardware System (2009), 3 descendants of its own
- K191032: fMRI Hardware System (2019), 2 descendants of its own
- K061255: Brainacquirerx / Brainprocessrx Data Suite Version 1.0 (2006), 2 descendants of its own

## Indications for use
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.

Source page: https://510kreport.com/device/K043290
Methodology: https://510kreport.com/methodology