# K092164: Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Delicate Electronics Co., Ltd.
- Decided: May 13, 2010 after 301 days
- Product code: OQQ (Diagnostic Ultrasonic Transducer, Robotic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K974588 (1998). 2 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K060112: Nodecrest Transcranical Doppler Ultrasound System, Nodecrest, LLC (2006) Summary page 2.

## Most influential descendants
- 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
- K213009: Transcranial Doppler Ultrasound System (2022), 0 descendants of its own

## Indications for use
The EMS9UA 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 Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. The EMS9UA 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. It is to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

Source page: https://510kreport.com/device/K092164
Methodology: https://510kreport.com/methodology