BEUDAMED
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    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

    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