BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QT SCANNER 2000 MODEL A

    MDR report key: 23433033 · Received October 30, 2025

    Report

    Report Number
    3011599810-2025-00001
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 28, 2025
    Manufacturer
    QT IMAGING HOLDINGS, INC.
    Product Code
    IYO
    UDI-DI
    00852619008003
    PMA / PMN Number
    K220933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDWATCH REPORT MW5176662 ALLEGES "FALSE ADVERTISING" AND A FAILURE TO DETECT AN ABNORMALITY THAT MAY BE MALIGNANT. QTI'S LABELING AND RELATED MATERIALS ALIGNED WITH THE QT SCANNER 2000 MODEL A'S 510(K) CLEARANCE (K220933). THERE IS NO EVIDENCE OF A DEVICE FAILURE OR MALFUNCTION.

    Description of Event or Problem · 0

    PATIENT PRESENTED FOR QTSCAN ON (B)(6) 2025 FOR EVALUATION OF A PALPABLE LUMP IN THE RIGHT BREAST. SHE REPORTED FEELING A LUMP FOR 3 WEEKS AND THE TECHNICIAN FORM COMPLETED BY THE SCAN TECHNOLOGIST AT THE CLINIC INDICATED THAT THE LUMP WAS LOCATED AT THE 3 O'CLOCK POSITION, IN THE AREOLAR EDGE OF THE RIGHT BREAST. HOWEVER, SUBSEQUENT HANDHELD ULTRASOUND (HHUS) AND DIAGNOSTIC MAMMOGRAPHY PERFORMED AT ANOTHER FACILITY ON (B)(6) 2025, FOCUSED ATTENTION AT THE 10 O'CLOCK POSITION, WHICH THE REPORT FROM THE OUTSIDE FACILITY INDICATED WAS THE SITE OF THE PALPABLE LUMP DENOTED BY THE PATIENT. THE IMAGING REPORT FROM THE OUTSIDE FACILITY DESCRIBED A HIGHLY SUSPICIOUS MASS WITH RECOMMENDATION FOR AN ULTRASOUND-GUIDED CORE BIOPSY OF THE MASS IN THE RIGHT BREAST AT 10 O'CLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084515 QT SCANNER 2000 MODEL A QTI BREAST ACOUSTIC CT SCANNER IYO QT IMAGING HOLDINGS, INC. A 00852619008003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other