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510(k) Data Aggregation

    K Number
    K170078
    Device Name
    Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
    Manufacturer
    Date Cleared
    2017-05-17

    (128 days)

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

    MEDISONO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vasculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gvn and Urology.
    Device Description
    The P11 Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The P1 Portable Diagnostic Ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D. The P11 EXPERT Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This P11 Expert Portable system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D. The P12 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The P12 Trolley Digital Color Doppler Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D. The P12 Expert Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. The system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The P25 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D. The P25 Expert Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. 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 data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
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    K Number
    K163688
    Device Name
    Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
    Manufacturer
    Date Cleared
    2017-02-23

    (57 days)

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

    MEDISONO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDISONO Ultraonic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatic patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta and Transvagina.
    Device Description
    The P1 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B3-Mode, M-Mode, B+M Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz- 10.0MHz. The system consists of a main unit, transducers and other accessories. The P3 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: B-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, a display and transducers. The P10 model is a portable Diagnostic Ultrasound System, which applies device advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Bmode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.
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