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510(k) Data Aggregation

    K Number
    K231659
    Device Name
    MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)
    Manufacturer
    Date Cleared
    2024-02-15

    (253 days)

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

    Medisono

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P9 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 plus are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric 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), Transrectal and Transvaginal.
    Device Description
    The P3 Plus Ultrasound Diagnostic System is a portable digital B/W compact ultrasound system with diagnostic B/W image quality and PW Doppler capability, applied in ultrasound diagnostic examination of abdominal, Vascular, Small Parts, Musculoskeletal, Obstetrics and Gynecology 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 six display modes: B-Mode, B+B, 4B Mode, M-Mode, and PW. This system controlled by software employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz- 11MHz. The system consists of a main unit, transducers, and other accessories. The P9 Plus Ultrasound Diagnostic System is a portable digital compact ultrasound system with multiple imaging modes applied in ultrasound diagnostic examination of f Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testicle, thyroid); Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Transrectal and Transvaginal applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, with multiple imaging modes: B-mode, C-mode, M-mode, CWmode, PW-mode, and PDI mode that employs an array of probes that include linear, Convex and Phase Array probes with a frequency range of approximately 2MHz- 11MHz. The system consists of a main unit, transducers, and other accessories. The P11 Plus Portable Digital Color Doppler Ultrasound System is a portable ultrasound system with Cardiac measurements, 4D. Elastography and Stress Echo capabilities. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; with complete imaging modes: 2D with THI, Color M, CFM, PDI, PW, HPRF, CW. This system contains an array of probes that include full range of Linear, Convex, Phased Array, Endocavity, TEE, Volumetric, and Biplane TRT probes with high density broadband transducers with Frequency up to 16 MHz. The system consists of a main unit, a display and transducers. The MS55 Plus Digital Color Doppler Ultrasound System is a diagnostic ultrasound system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology. Various image parameter adjustments, 22-inch touchscreen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, SR-Flow mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include phased array, convex array, and abdominal volume probe. The P12 Plus Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies device advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. Various image parameter adjustments. 22-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe with frequency ranges of 1.9 MHz to 17MHZ. The P25 Expert Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging, Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Transvaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology, Various image parameter adjustments, 22-inch LED, 13.3-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in 2D with THI, Color M, CFM, PDI, PW, HPRF, CW, Contrast Imaging, Elastography, Stress Echo. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe probes, wide scanning Angle Endocavity Probe with frequency ranges of 1.9 MHz to 17MHZ.
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    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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