# K141462: Varia-Nci

- Pathway: 510(k) (Traditional)
- Applicant: Neurochaos Solutions, Inc.
- Decided: Nov 19, 2014 after 169 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K931801 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051085: Doppler-Box, Compumedics Germany Gmgh (2005) Summary page 4.

## Indications for use
Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity. Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

Source page: https://510kreport.com/device/K141462
Methodology: https://510kreport.com/methodology