BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

    K Number: K243540 · Decision Dec 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    31
    Review Days
    27

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    Basic Information

    Device Name
    Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
    K Number
    K243540
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies, Inc.
    Date Received
    November 15, 2024
    Decision Date
    December 12, 2024
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Ge Medical Systems Information Technologies, Inc.

    K Number Device Name
    K251670 MAC 7 Resting ECG Analysis System
    K242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
    K233810 Portrait VSM
    K234130 Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O
    K231870 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
    K230626 Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™
    K230145 ONE-CUF
    K222586 Mural Clinical Viewer
    K221904 EK12 V2 Algorithm
    K221321 MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
    Search all 31 clearances from Ge Medical Systems Information Technologies, Inc. →