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510(k) Data Aggregation

    K Number
    K233697
    Device Name
    SonoMax Series Digital Color Doppler Ultrasound System
    Date Cleared
    2024-08-09

    (266 days)

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

    CHISON Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.
    Device Description
    The SonoMax Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.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 echo data and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic lmaging modes or a combination of these mode.
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    K Number
    K223570
    Device Name
    SonoAir Series Digital Color Doppler Ultrasound System
    Date Cleared
    2023-03-31

    (122 days)

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

    CHISON Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
    Device Description
    The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.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 echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
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    K Number
    K202457
    Device Name
    M1 Surgical Face Mask
    Date Cleared
    2021-04-29

    (245 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHISON Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
    Device Description
    Not Found
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    K Number
    K201965
    Device Name
    SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
    Date Cleared
    2021-03-02

    (230 days)

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

    Chison Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
    Device Description
    The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes: - A commercial off-the-shelf (COTS) Android mobile device . - . CHISON Ultrasound software is running as an app (Android) on the COTS device - . The SonoEye P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.
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    K Number
    K201967
    Device Name
    SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
    Date Cleared
    2021-02-26

    (226 days)

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

    Chison Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
    Device Description
    The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes: - A commercial off-the-shelf (COTS) Android mobile device - CHISON Ultrasound software is running as an app (Android) on the COTS device - The SonoEye P2, SonoEye V2, SonoEye G2 Linear array USB transducer
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    K Number
    K201968
    Device Name
    SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
    Date Cleared
    2021-02-26

    (226 days)

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

    Chison Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined (B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
    Device Description
    The SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P3 Series Digital Color Doppler Palm Ultrasound System includes: - · A commercial off-the-shelf (COTS) Android mobile device - CHISON Ultrasound software is running as an app (Android ) on the COTS device - The SonoEye P3, SonoEye V3, SonoEye G3 Phase array USB transducer
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    K Number
    K201969
    Device Name
    SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
    Date Cleared
    2021-02-25

    (225 days)

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

    Chison Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Cardiac, Abdomen. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
    Device Description
    The SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P6/SonoEye V6/SonoEye G6 is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes: - A commercial off-the-shelf (COTS) Android mobile device. - CHISON Ultrasound software is running as an app (Android) on the COTS device. - The SonoEye P6/SonoEye V6/SonoEye G6 support Convex array transducer.
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    K Number
    K201971
    Device Name
    SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
    Date Cleared
    2021-02-25

    (225 days)

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

    Chison Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Fetal, Abdominal, OB/GYN, Urology, Cardiac. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
    Device Description
    The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System includes: - · A commercial off-the-shelf (COTS) Android mobile device - CHISON Ultrasound software is running as an app (Android ) on the COTS device - The SonoEye P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer
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    K Number
    K200780
    Device Name
    XBit Series Digital Color Doppler Ultrasound System
    Date Cleared
    2020-08-05

    (133 days)

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

    CHISON Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
    Device Description
    The XBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LED monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D. Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.
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    K Number
    K180974
    Device Name
    CBit Series Digital Color Doppler Ultrasound System
    Date Cleared
    2018-08-17

    (126 days)

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

    CHISON Medical Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.
    Device Description
    The CBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . 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 echo data and to display the image B-Mode (including Fusion Harmonic Imaging). M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
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