510(k) K162314 ยท JAK System, X-Ray, Tomography, Computed
IMACTIS CT-Navigation system
| Applicant | Imactis, Sas, La Tronche, FR |
| Decision | Substantially Equivalent, Apr 24, 2018 |
| Received | Aug 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | GE Medical Systems, LLC Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP Open, Classified |
JAK | None listed |
| Feb 11, 2021 | Imactis Impactis NaviKit-stereotaxic accessory for Computed Tomography systems
Reference # I10100 Terminated |
JAK | None listed |
| Aug 24, 2020 | Imactis Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180) Open, Classified |
JAK | None listed |
| Aug 1, 2019 | Imactis 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 in Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.