# K213009: Transcranial Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Delica Medical Equipment Co., Ltd.
- Decided: Jul 8, 2022 after 291 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: 5 generations back to K974588 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 6.

## Indications for use
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 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 Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler 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. This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode

Source page: https://510kreport.com/device/K213009
Methodology: https://510kreport.com/methodology