IMACTIS CT-Navigation system— 510(k) K162314
Substantially EquivalentImactis, Sas
FDA 510(k) clearance K162314 for IMACTIS CT-Navigation system, Substantially Equivalent on 2018-04-24. Applicant: Imactis, Sas. Device class: 2.
Clearance details
- Applicant
- Imactis, Sas
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Tronche, FR
Recent devices under product code JAK
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162314
K-number listed on FDA's recall record- Z-1590-2026 — Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
- Z-1264-2021 — Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Z-2972-2020 — Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
- Z-0838-2020 — 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,
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162314.
Data sourced from openFDA. This site is unofficial and independent of the FDA.