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    PHASE DIAGNOSTICS

    FDA registration
    PHASE DIAGNOSTICS·4 products·🇺🇸 United States

    INDICAID health Sexual Health 2

    FDA UDI
    Phase Diagnostics, Inc.·00810113420028·A collection of noninvasive devices intended to...

    BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75

    FDA 510(k)
    FDA Class 1 ·Radiology

    INDICAID COVID-19 RAPID ANTIGEN AT HOME TEST

    FDA Adverse Event
    Malfunction ·PHASE DIAGNOSTICS·Product code QKP·December 5, 2025

    SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350

    FDA 510(k)
    FDA Class 1 ·Radiology

    SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650

    FDA 510(k)
    FDA Class 1 ·Radiology

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MNB·June 26, 2013

    THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100

    FDA 510(k)
    FDA Class 1 ·Radiology

    THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80

    FDA 510(k)
    FDA Class 1 ·Radiology

    CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·December 20, 2013

    MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 6, 2015

    Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 29, 2017

    ANTI-D FOR SLIDE AND MODIFIED TUBE TESTS

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·December 28, 2009

    ANTI-D FOR SLIDE AND MODIFIED TUBE TESTS

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·December 28, 2009