# K190228: Transcranial Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Delica Medical Equipment Co., Ltd.
- Decided: Jun 13, 2019 after 128 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: 11 generations back to K902859 (1991). 96 ancestors in all.
No later device cites it as a predicate yet.
4 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173801: Transcranial Doppler Ultrasound System, Shenzhen Delica Medical Equipment Co., Ltd. (2018) Summary page 14.
- K173916: Finapres Nova Noninvasive Hemodynamic Monitor, Finapres Medical Systems B.V. (2018) Summary page 14.
- K182433: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff, Shenzhen Caremed Medical Technology Co., Ltd. (2018) Summary page 14.

## Indications for use
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemo-dynamically 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 robotic probe headband facilitates monitoring use by its ability to track the Doppler signal. While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject’s finger. Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The system is intended for use during: 1) Diagnostic exams; 2) 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. The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.

Source page: https://510kreport.com/device/K190228
Methodology: https://510kreport.com/methodology