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510(k) Data Aggregation

    K Number
    K161119
    Device Name
    SonoSite iViz Ultrasound System
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2016-05-13

    (23 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric
    Device Description
    The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.
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    K Number
    K153626
    Device Name
    SonoSite Edge II Ultrasound System
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2016-01-20

    (33 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUJIFILM SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
    Device Description
    The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.
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    K Number
    K152983
    Device Name
    FUJIFILM SonoSite iViz Ultrasound System
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2015-11-12

    (34 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB Abdominal Pediatric Cardiac Adult Cardiac Pediatric
    Device Description
    The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.
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    K Number
    K152209
    Device Name
    FUJIFILM SonoSite X-Porte Ultrasound System
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2015-08-19

    (12 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel
    Device Description
    The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
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    K Number
    K133454
    Device Name
    SONOSITE EDGE ULTRASOUND SYSTEM
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2013-12-16

    (34 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
    Device Description
    The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
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    K Number
    K133134
    Device Name
    X-PORTE ULTRASOUND SYSTEM
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2013-11-04

    (34 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel
    Device Description
    The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
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    K Number
    K130173
    Device Name
    SONOSITE MAXX SERIES ULTRASOUND SYSTEM
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2013-03-25

    (60 days)

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

    FUJIFILM SONOSITE,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
    Device Description
    The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.
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