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510(k) Data Aggregation

    K Number
    K981834
    Device Name
    PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    Date Cleared
    1998-09-29

    (126 days)

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

    PERCEPTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Small Organ (Breast, Thyroid, Testes), Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional.
    Device Description
    The Perception's GPS-6TBMD Ultrasound System is a PC (computer) based and controlled real time. two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-6TBMD Diagnostic Ultrasound System supports M. B. M&B, Dual B, Quad B, D and D/B, display modes. All probes currently intended for use with the Perception GPS-6TBMD Diagnostic Ultrasound System are either mechanical sector devices or electronic linear and curve array, and make use of a fluid filled design.
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    K Number
    K974880
    Device Name
    PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    Date Cleared
    1998-06-08

    (160 days)

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

    PERCEPTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Peripheral Vascular.
    Device Description
    The Perception's GPS-RST Ultrasound System is a PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-RST Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-RST Diagnostic Ultrasound System supports M, B, M&B, Dual B, Quad B. D and D/B, display modes. All probes currently intended for use with the Perception GPS-RST Diagnostic Ultrasound System are either mechanical sector devices or electronic linear array, and make use of a fluid filled design.
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    K Number
    K972192
    Device Name
    PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    Date Cleared
    1997-12-17

    (190 days)

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

    PERCEPTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GPS-XYZ device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device.
    Device Description
    The GPS-XYZ Diagnostic Ultrasound System device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There are no transcranial applications for this device. User interface is via an alphanumeric keypad and integrated trackball. The Perception Inc. GPS-XYZ Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS -XYZ Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -XYZ Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.
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    K Number
    K972973
    Device Name
    PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    Date Cleared
    1997-10-15

    (65 days)

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

    PERCEPTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.
    Device Description
    The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.
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