# K060112: Nodecrest Transcranical Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Nodecrest, LLC
- Decided: May 5, 2006 after 108 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: 1 generation back to K974588 (1998). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974588: Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral Transcranial Doppler Device, Compact Mod, Rimed, Ltd. (1998) Summary page 2.

## Most influential descendants
- K092164: Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA (2010), 7 descendants of its own
- K122710: Transcranial Doppler with Robotic Probe Headband (2013), 5 descendants of its own
- K173801: Transcranial Doppler Ultrasound System (2018), 2 descendants of its own
- K180455: NeuralBot (2018), 1 descendant of its own
- K254143: EM-TECH Passive Ultrasound Probe Strap (2026), 0 descendants of its own

## Indications for use
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values 2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Nodecrest Transcranial Doppler is intended for use during: a) Diagnostic exams b) Surgical interventions The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Source page: https://510kreport.com/device/K060112
Methodology: https://510kreport.com/methodology