# DEN130033: Cognivue

- Pathway: De Novo (Direct)
- Applicant: Cerebral Assessment Systems, Inc.
- Decided: Jun 5, 2015 after 723 days
- Product code: PKQ (Computerized Cognitive Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K150154: ANAM Test System: Military Battery (2015), 7 descendants of its own
- K161068: Ahead 300 (2016), 6 descendants of its own
- K181179: BrainScope One (2018), 5 descendants of its own
- K183241: BrainScope TBI (Model: Ahead 400) (2019), 3 descendants of its own
- K190815: BrainScope TBI (2019), 2 descendants of its own

## Indications for use
indicated for use as an adjunctive tool for evaluating perceptual and memory function in individuals aged 55-95 years old

Source page: https://510kreport.com/device/DEN130033
Methodology: https://510kreport.com/methodology