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510(k) Data Aggregation

    K Number
    K213972
    Device Name
    Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
    Manufacturer
    GE Healthcare Information Technologies, Inc.
    Date Cleared
    2022-02-17

    (59 days)

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

    GE Healthcare Information Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements, which may then be displayed, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations. The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefft from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements, which may then be displayed filtered, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations. The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
    Device Description
    Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP) recording systems, respectively. A third configuration, ComboLab, allows the user to access both CardioLab and Mac-Lab functions, though only one application may be accessed at a time. These devices are used during interventional and related procedures to process, display and record hemodynamic and electrophysiology (EP) data depending on the type of procedure performed. The data is acquired and displayed real-time for multiple physiological parameters to allow the user to view the data. The data may be entered manually through the use of a dedicated keyboard/mouse/barcode scanner or acquired via procedural information devices, imaging devices and interfaced data devices, and may then be displayed, filtered, digitized, amplified, measured, and calculated. A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available for installation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). The MLCL Review Software may be used to record, document, analyze, store and transmit data, including data from supported patient monitors. Mac-Lab, CardioLab, ComboLab and the MLCL Client Software provide the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity but may also be used stand-alone (not connected to a network). Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are not intended to be used as a patient monitor and are not intended to alert the licensed health care practitioner of a change in patient status.
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