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510(k) Data Aggregation

    K Number
    K232285
    Device Name
    U-Lite PRO
    Manufacturer
    Sonoscanner SARL
    Date Cleared
    2024-01-11

    (164 days)

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

    Sonoscanner SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals. It can therefore be used in different configurations, especially: - In medical offices (general practitioner's office) - In clinics & hospitals (incl. in emergency and critical care units) - In a field hospital It is used in imaging or examinations rooms. It can be used at the bedside. It is not intended for direct use in a sterile environment. The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system. U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: - ophthalmic - fetal/obstetric, - gynecological, - abdominal, - pediatric, - neonatal cephalic - adult cephalic - small organ, - trans-vaginal, - trans-rectal, - cardiac adult & pediatric - peripheral vascular, - urology (including prostate) - musculoskeletal (both conventional and superficial) Note : The application fields are dependent on the selected probes and the modes of operations. Modes of operations include: - B-Mode (B) - M-Mode (M) - Color Doppler (CD) - Power Doppler (PD) - Spectral Pulsed-Wave Doppler (PWD) - Continous Wave Doppler (CWD) - Combined :(B+M; B+CD; B+ PD; B+PWD)
    Device Description
    U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner. The U-Lite PRO is a notebook-size, battery-operated, generalpurpose track 3 diagnostic ultrasound system. The U-Lite PRO can be handheld measuring 180mm x 115mm x 20mm and weighing 0.7 kg (approximately 1.54 lbs.). The unit is a handheld ultrasound (HHU) imaging system with interchangeable probes with optional stand. The U-Lite PRO is used to acquire and display high-resolution LED screen images, realtime ultrasound data and display the data as B Mode, M Mode, PWD Mode, CWD Mode, Color Doppler Mode, Power Doppler, Tissue Harmonic Imaging Mode, and Combined (B +M; B+CD; B+PD; B+PWD).
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    K Number
    K201988
    Device Name
    T-Lite
    Manufacturer
    Sonoscanner
    Date Cleared
    2020-10-30

    (105 days)

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

    Sonoscanner

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Lite ultrasound system is intended for use by an appropriately- trained healthcare professional. We recommend that all users receive proper training by an authorized Sonoscanner representative before attempting to use the scanner. You must also follow corresponding local government rules and guidelines at all times. T-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: - fetal/obstetric. gynecological, abdominal. pediatric, small organ, trans-vaginal, trans-rectal, cardiac. peripheral vascular. urology, musculoskeletal (both conventional and superficial), neonatal cephalic NOTE : The application fields are dependent on the selected probe. NOTE : T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially: - in medical offices, - in clinics, - in hospitals. It is used in imaging or examination rooms. It can be used at the bedside. It is not intended for direct use in a sterile environment. NOTE : The T-Lite is not compatible with the use of the HF surgery device or in an MRI system. Modes of operation include: · B-Mode - · B-Mode + M-Mode - · B-Mode + Color Doppler - · B-Mode + Power Doppler - · Spectral Pulsed-Wave Doppler
    Device Description
    T-Lite is a compact, ultralight, battery powered general purpose diagnostic ultrasound scanner. The T-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. The T-Lite can be handheld measuring 253mm x 19mm and weighing just 1kg (approximately 2.2lbs). The unit has a built-in kick stand or optional stand. The T-Lite is used to acquire and display high-resolution LED screen images, real-time ultrasound data and display the data as B Mode, M Mode, PWD Mode, Color Doppler Mode, Color Power Doppler, Duplex Mode, Tissue Harmonic Imaging Mode, Tissue Doppler and Combined (B + Color Doppler Mode).
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    K Number
    K171164
    Device Name
    U-Lite EXP
    Manufacturer
    Sonoscanner
    Date Cleared
    2017-08-03

    (105 days)

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

    Sonoscanner

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: Abdominal Small Parts Vascular Cardiac Obstetrics Gynecology Fetal Pediatrics
    Device Description
    The U-Lite EXP are notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and display the data as B Mode, Color Mode, Power Doppler Imaging, and Pulse Wave Doppler spectrum. The handheld U-Lite EXP tablet's display is a high-resolution 7-inch color LED screen and the controls are intuitive and easy to use. Controls are touch-activated – there are no knobs or switches. The U-Lite EXP is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.
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    K Number
    K143601
    Device Name
    U-Lite
    Manufacturer
    Sonoscanner SARL
    Date Cleared
    2015-03-18

    (90 days)

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

    Sonoscanner SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: fetal/obstetric, gynecological, abdominal, pediatric, small organ, trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology, and musculoskeletal (both conventional and superficial). The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals (physician, sonographer, etc.) for diagnostic ultrasound imaging and fluid flow analysis of the human body. Utilizing curved, linear, phased array, and endocavitary probes, the U-Lite allows for a wide range of clinical applications: Fetal/obstetric, gynecological, abdominal, pediatric, small organ, transvaginal, trans-rectal, cardiac, peripheral vascular, and musculoskeletal.
    Device Description
    U-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and to display the data as B Mode, M Mode, Color Mode, Power Doppler imaging, and Pulse Wave Doppler spectrum. The U-Lite device utilizes a standard range of probes, including curved array (convex), linear array, phased array (sector), and endocavitary transducers. The handheld U-Lite tablet's display is a high-resolution 7 inch color LED screen, and the controls are intuitive and easy to use. Controls are touch-activated - there are no knobs or switches. The U-Lite is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.
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