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510(k) Data Aggregation

    K Number
    K023255
    Device Name
    TECHNOS MP, MODEL AU6
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2003-02-11

    (134 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology. The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
    Device Description
    The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
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    K Number
    K014168
    Device Name
    AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2002-04-25

    (127 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.
    Device Description
    Not Found
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    K Number
    K020164
    Device Name
    E-SCAN XQ
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2002-02-12

    (26 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
    Device Description
    The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.
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    K Number
    K012728
    Device Name
    E-SCAN MRI SYSTEM
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2001-08-29

    (14 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
    Device Description
    The E-scan is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
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    K Number
    K010405
    Device Name
    7230 ULTRASOUND IMAGING SYSTEM WITH TEI
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2001-03-13

    (29 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010057
    Device Name
    MODIFICATION TO ARTOSCAN M
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2001-02-02

    (25 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001894
    Device Name
    MODIFICATION TO E-SCAN
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2000-07-06

    (15 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000931
    Device Name
    AU5 ULTRASOUND IMAGING SYSTEM
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2000-06-08

    (78 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000681
    Device Name
    AU5, AU6
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2000-05-03

    (65 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994369
    Device Name
    7250 (MEGAS)
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Date Cleared
    2000-02-24

    (59 days)

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

    BIOSOUND ESAOTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular. Applicable combined modes: B+M+PW+CW+CFM+PD. New indication: Tissue Harmonic Imaging for Cardiac.
    Device Description
    ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption. The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.
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