Imactis
FDA Regulatory Profile
Imactis appears in FDA public data with 3 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1264-2021, Class II) was initiated on February 11, 2021. Its most recent 510(k) clearance was granted on April 24, 2018.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1264-2021 | Class II | Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 | February 11, 2021 |
| Z-2972-2020 | Class II | Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction wit | August 24, 2020 |
| Z-0838-2020 | Class II | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover R | August 1, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162314 | IMACTIS CT-Navigation system | April 24, 2018 |