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    IMACTIS, SAS

    FDA registration
    IMACTIS, SAS·2 products·🇫🇷 France

    IMACTIS®

    FDA UDI
    IMACTIS·B681J020000·Navigation station of the IMACTIS® CT-NAVIGATIO...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J00099US0·Power cable of the IMACTIS® CT-NAVIGATION system

    IMACTIS®

    FDA UDI
    IMACTIS·B681A102001·Non-sterile needle holder of the IMACTIS® CT-NA...

    IMACTIS®

    FDA UDI
    IMACTIS·B681A100101·Sterile needle holder of the IMACTIS® CT-NAVIGA...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J001971·Transport suitcase for the navigation station o...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J000970·Cart for the IMACTIS® CT-NAVIGATION system

    IMACTIS®

    FDA UDI
    IMACTIS·B681I101002·Single use Navigation Kit of the IMACTIS® CT-NA...

    IMACTIS CT-Navigation system

    FDA 510(k)
    FDA Class 2 ·Radiology

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Recall
    Open, Classified ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·August 1, 2019

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Recall
    Terminated ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·February 11, 2021

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    FDA Recall
    Open, Classified ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·August 24, 2020

    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code JAK·February 3, 2026

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    FDA Enforcement
    Class II ·Ongoing·Imactis·September 23, 2020

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Imactis·January 29, 2020

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Enforcement
    Class II ·Terminated·Imactis·March 24, 2021

    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·April 1, 2026

    IMC Ti Insert

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307118725·

    ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·November 6, 2019

    ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·November 6, 2019