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510(k) Data Aggregation

    K Number
    K251830
    Device Name
    Sonosite LX Ultrasound System
    Manufacturer
    FUJIFILM Sonosite, Inc.
    Date Cleared
    2025-07-10

    (27 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
    Device Description
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    K Number
    K213763
    Device Name
    Sonosite PX Ultrasound System
    Manufacturer
    FUJIFILM Sonosite, Inc.
    Date Cleared
    2021-12-27

    (26 days)

    Product Code
    IYN, ITX, IYO, OIJ
    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 PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal, Adult cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate), Transvaginal, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
    Device Description
    The Sonosite PX 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 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
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    K Number
    K200964
    Device Name
    Sonosite PX Ultrasound System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2020-05-08

    (28 days)

    Product Code
    IYN, ITX, IYO, OIJ
    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 PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Needle Guidance This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthicare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
    Device Description
    The Sonosite PX 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 2D, M-Mode (including Simultaneous M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. The Sonosite PX Ultrasound System also includes needle guidance capability. The system is capable of working with two different types of needle guide brackets available, including 1) Fixed-angle, in-plane brackets where a pair of guidelines are generated that represent the path of the needle and 2) Transverse-angle, out-of-plane brackets (adjustable depths) where the quidelines appear down the center of the imaqe. Each Sonosite PX transducer has an appropriate needle quide bracket kit to support needle quidance with the system.
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    K Number
    K190476
    Device Name
    FUJIFILM Sonosite Vevo MD Imaging System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2019-03-15

    (16 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 Vevo MD Imaging System is a general purpose imaging 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: Abdominal Dermatological Musculoskeletal (conventional) Musculoskeletal (superficial) Neonatal Cephalic Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate)
    Device Description
    The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
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    K Number
    K183235
    Device Name
    SonoSite SII Ultrasound System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2019-02-07

    (79 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 SII 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-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
    Device Description
    The SonoSite SII Ultrasound System is a mountable 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. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
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    K Number
    K180704
    Device Name
    SonoSite iViz Ultrasound System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2018-04-13

    (25 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 for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
    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
    K171437
    Device Name
    SonoSite X-Porte Ultrasound System
    Manufacturer
    FujiFilm SonoSite, Inc.
    Date Cleared
    2017-06-12

    (27 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 X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of thid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal 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 readily 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
    K162288
    Device Name
    SonoSite iViz Ultrasound System
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Date Cleared
    2016-09-08

    (24 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 Peripheral vessel
    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
    K162045
    Device Name
    SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2016-08-18

    (24 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 II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging 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-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel The SonoSite SII 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-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
    Device Description
    SONOSITE EDGE II ULTRASOUND SYSTEM: 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. SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable 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. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
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    K Number
    K160674
    Device Name
    Fujifilm Sonosite Vevo MD Imaging System
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Date Cleared
    2016-04-19

    (40 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 Vevo MD Imaging System is a general purpose imaging 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: Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostrate) Musculoskeletal (conventional) Musculoskeletal (superficial) Peripheral vessel Dermatological
    Device Description
    The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
    Ask a Question

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