# K141865: DANA

- Pathway: 510(k) (Traditional)
- Applicant: Anthrotronix, Inc.
- Decided: Oct 15, 2014 after 97 days
- Product code: LQD (Recorder, Attention Task Performance)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854903 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122149: QBTES, Qbtech AB (2012) Summary page 4.

## Indications for use
DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, dementia, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress). DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

Source page: https://510kreport.com/device/K141865
Methodology: https://510kreport.com/methodology