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510(k) Data Aggregation

    K Number
    K211321
    Device Name
    Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
    Manufacturer
    Guangzhou Sonostar Technologies Co., Ltd.
    Date Cleared
    2022-10-13

    (531 days)

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

    Guangzhou Sonostar Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device to contact with the patient is the probe head.
    Device Description
    The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system. The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging. The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
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    K Number
    K172750
    Device Name
    Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
    Manufacturer
    Guangzhou Sonostar Technologies Co., Ltd.
    Date Cleared
    2018-02-28

    (169 days)

    Product Code
    IYO, ITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Sonostar Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging. The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
    Device Description
    The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system. The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc. The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap. The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen. The device components are not supplied sterile and do not require sterilization prior to use.
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    K Number
    K171926
    Device Name
    C5 Diagnostic Ultrasound System
    Manufacturer
    Guangzhou Sonostar Technologies Co., Ltd.
    Date Cleared
    2017-10-27

    (122 days)

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

    Guangzhou Sonostar Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
    Device Description
    The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").
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