Search Filters

Search Results

Found 25 results

510(k) Data Aggregation

    K Number
    K082224
    Device Name
    DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2008-12-15

    (131 days)

    Product Code
    ITX, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
    Device Description
    The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes. Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.
    Ask a Question
    K Number
    K071287
    Device Name
    ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2008-01-09

    (246 days)

    Product Code
    ITX, IYN, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional. Small Organ (Specify): Thyroid, Testicles, Breast.
    Device Description
    The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.
    Ask a Question
    K Number
    K071289
    Device Name
    ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2008-01-09

    (246 days)

    Product Code
    ITX, IYN, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
    Device Description
    The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
    Ask a Question
    K Number
    K071291
    Device Name
    ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2008-01-09

    (246 days)

    Product Code
    ITX, IYN, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Small Organ (Specify): Thyroid, Testicles, Breast. Other (Specify): Real time 3D.
    Device Description
    The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
    Ask a Question
    K Number
    K061643
    Device Name
    ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2006-07-27

    (45 days)

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

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Transrectal, Peripheral Vascular, Musculo-skeletal Conventional, and Musculo-skeletal Superficial.
    Device Description
    The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.
    Ask a Question
    K Number
    K061637
    Device Name
    ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2006-07-25

    (43 days)

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

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal. Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M), B/CWD, CFM(B)/CWD), Tissue Harmonic Imaging.
    Device Description
    The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.
    Ask a Question
    K Number
    K061641
    Device Name
    ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2006-07-14

    (32 days)

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

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
    Device Description
    The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.
    Ask a Question
    K Number
    K052500
    Device Name
    DAR-8000F
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2005-10-17

    (34 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the radiography in the hospital with X-ray devices. The object of this device is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.
    Device Description
    Not Found
    Ask a Question
    K Number
    K052076
    Device Name
    DAR-8000I
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2005-09-02

    (32 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for radiography in the hospital with X-ray devices.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050510
    Device Name
    ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2005-04-01

    (31 days)

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

    SHIMADZU MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
    Device Description
    The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convox array, and sector probe with a frequency range of approximately 2 to 15 MHz. The system can operate in B mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.
    Ask a Question

    Page 1 of 3