Data / Medical devices / France / Imactis, SAS
Imactis, SAS: FDA-registered device maker in Saint Martin D'Heres, France, 1 510(k) clearance
Imactis, SAS is registered with the FDA (registration 3015060224) in Saint Martin D'Heres, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2018. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015060224
- Address
- 20 rue du Tour de l'eau, Saint Martin D'Heres, France, 38400
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer
- First device listed
- December 17, 2024
- Registered through
- 2027
- Brand names listed
- IMACTIS CT-Navigation system, Imactis Mobile Cart, USMAN MAGNETIC NAVIGATION STATION
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2018 | K162314 | IMACTIS CT-Navigation system | JAK | Substantially Equivalent | Imactis, Sas | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 11, 2021 | 87391 | Class II | Terminated | Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 | Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs o | accessdata.fda.gov |
| August 24, 2020 | 85258 | Class II | Ongoing | Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180) | The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory. | accessdata.fda.gov |
| August 1, 2019 | 84460 | Class II | Ongoing | 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 diamete | The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level | accessdata.fda.gov |
Compare with other makers
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of System, X-Ray, Tomography, Computed
Updated April 24, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.