BEUDAMED
    Product Code: PBZ FDA class 2 21 CFR 880.2750

    Image Processing Device For Estimation Of External Blood Loss

    General Hospital

    The Image Processing Device for Estimation of External Blood Loss is a software-based device used as an aid in estimating patient external blood loss, providing clinical teams with more objective measurement data to guide transfusion and resuscitation decisions. It falls under the General Hospital medical specialty and is classified as a Class 2 device under regulation 880.2750, requiring 510(k) premarket notification. The device is subject to general controls and special controls. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    12

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    Basic Information

    Product Code
    PBZ
    Device Class
    FDA class 2
    Regulation Number
    880.2750
    Medical Specialty
    General Hospital
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K252282 SurgiCount+ System
    K232250 SurgiCount+ System
    K163507 Triton Sponge System
    K160338 Triton System
    K142801 Triton Canister System
    DEN130015 PIXEL 3 SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.