BEUDAMED
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    Lunit INSIGHT DBT

    FDA UDI
    Lunit Inc.·08800076000148·

    Lunit INSIGHT DBT

    FDA UDI
    Lunit Inc.·08800076000162·

    Lunit INSIGHT DBT

    FDA UDI
    Lunit Inc.·08800076000230·

    Lunit INSIGHT DBT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DBT, DYNAMIC BUBBLE TRAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lunit INSIGHT DBT (V1.2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lunit INSIGHT DBT v1.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code OTE·February 28, 2019

    ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code OTE·February 28, 2019

    SMALL PATCH LEAD A67

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code LWS·November 7, 1997

    MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

    FDA Adverse Event
    Death ·HOLOGIC INC.·Product code OTE·March 3, 2021

    1LYR 16FR10ML SILVER SAFE DB T

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES LP·Product code OHR·December 19, 2024

    COBAS 8000 ISE 1800 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 1, 2025

    MAXIM ILOK ANA PRI FML 65 RT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·April 13, 2016

    BIOMET CC I-BEAM TRAY 71MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·April 13, 2016

    BREVERA BREAST BIOPSY SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code KNW·January 30, 2023

    ELOX EX 60-BP

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DBT·February 13, 2026

    ACCEL CR TIB BRNG 10X71/75

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·April 13, 2016

    MAX PRI DCM TIB BRNG10X71/75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·April 13, 2016

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025