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510(k) Data Aggregation

    K Number
    K213009
    Device Name
    Transcranial Doppler Ultrasound System
    Date Cleared
    2022-07-08

    (291 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Delica Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended 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
    Device Description
    The EMS-9M1 and EMS-9M2 Transcranial Doppler Ultrasound System is a Transcranial Doppler (TCD) system using non-invasive technique to obtain the information of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow. Both the EMS-9Ml and EMS-9M2 are Track 1 devices. EMS-9M1 and EMS-9M2 should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
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    K Number
    K190228
    Device Name
    Transcranial Doppler Ultrasound System
    Date Cleared
    2019-06-13

    (128 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Delica Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended 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 cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and 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 noninyasive 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.
    Device Description
    EMS-9D PRO and EMS-9D EXP are Transcranial Doppler (TCD) ultrasound system, which is developed based on the EMS-9D, it inherits all the EMS-9D's hardware and mechanical structure design. EMS-9D PRO and EMS-9D EXP are not only a Transcranial Doppler ultrasound system which used non-invasive technique to obtain the information of blood flow velocities throughout the body, but also a blood pressure monitor. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain, and continuously measuring blood pressure. TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow. The EMS-9D PRO and EMS-9D EXP integrate main unit, TCD probes, Nano Core module, upper arm blood pressure module and analog output module (EMS-9D EXP only), dedicated software, remote control, headframe, upper arm cuff, finger cuff and optional probes. EMS-9D EXP/EMS-9D PRO should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
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    K Number
    K173801
    Device Name
    Transcranial Doppler Ultrasound System
    Date Cleared
    2018-07-11

    (209 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Delica Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended 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 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.
    Device Description
    The EMS-9D/EMS-9F Transcranial Doppler Ultrasound System is a Transcranial Doppler (TCD) system using non-invasive technique to obtain the information of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow. EMS-9D/EMS-9F should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
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