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510(k) Data Aggregation

    K Number
    K103678
    Device Name
    CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
    Date Cleared
    2011-02-16

    (62 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CASE Cardiac Testing System and CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CASE is a turnkey product utilizing the CS software. The CS will be offered as a software only package including o front end for data acquisition. CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE Cardiac Testing System and CS Cardioc Testing System are designed to acquire, process, record, archive, and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time without arrhythmia detection. The arrhythmia detection portion of CASE Cardiac Testing System and CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CASE Cardiac Testing System and CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electronic/digital storage system via network. CASE Cardiac Testing System and CS Cardiac Testing System provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. CASE Cardiac Testing System and CS Cardiac Testing System can be configured in a network environment for multiple CASE stations and CS stations allowing the user to create a central database of patient demographics and collected patient physiological data. CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed. CASE Cardiac Testing System and CS Cardiac Testing System offer no diagnostic opinion to the user. Instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion. CASE Cardiac Testing System and CS Cardiac Testing System are not intended to be used as a transport device or for home use. CASE Cardiac Testing System and CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor or for intracardiac use.
    Device Description
    The CASE Cardiac Testing System and the CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CS Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE Cardiac Testing System is a turnkey product utilizing the CS Cardiac Testing software. CASE Cardiac Testing System and the CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE Cardiac Testing System and the CS Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CASE Cardiac Testing System and the CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The CS Cardiac Testing System was formerly named Cardiosoft.
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    K Number
    K091594
    Device Name
    HEART-EXERCISE
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
    Date Cleared
    2009-07-29

    (57 days)

    Product Code
    MHX, DOK
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results. The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user. The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.
    Device Description
    HEART-Exercise is an algorithm library for exercise testing systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.
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    K Number
    K000638
    Device Name
    RESPONDER 3000
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
    Date Cleared
    2000-10-30

    (248 days)

    Product Code
    MKJ, CCK, DQA, LDD
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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