# K052571: Mindstate Functional Data Acquisition Device (Fdad), Version 1.0

- Pathway: 510(k) (Special)
- Applicant: Neurognostics, Inc.
- Decided: Oct 17, 2005 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K093336: Integrated Stimulus Delivery System Optimum and Premium (2010), 0 descendants of its own

## Indications for use
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI cnv1rfITr'leIt to perform (unctional MRI (fMR.I) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. [DAD presents a stimulus to the patient mid collects the patient's responses by the palieril in response to a set of stimuli creates the necessary behavioral data- the tMRI data comprised of the MRP images (in DICOM tbrmal) sent from the MR scanner control station, and the behavioral response (binary) data arc archived to a removable media by tDAD. The tDAD-PT ([DAD Personal 'frainer) 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 f'DAD-YI control stalion andof the response to be provided.

Source page: https://510kreport.com/device/K052571
Methodology: https://510kreport.com/methodology