Imactis, SAS

Saint Martin D'heres, FR

IMACTIS, SAS appears in FDA device records in Saint Martin D'heres, FR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Imactis, SAS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Imactisenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Imactis, SAS in 2018.

Clearances by year, as a table

510(k) clearance decisions for Imactis, SAS, by decision year
Year	Clearances
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K162314	IMACTIS CT-Navigation system	JAK	Substantially Equivalent	2018-04-24

Registered establishments

FDA registered establishments for Imactis, SAS, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015060224	3015060224	IMACTIS, SAS	20 rue du Tour de l'eau, SAINT MARTIN D'HERES 38400 FR	2026	BZN JAK

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1264-2021	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 or vasculature adjacent to the trajectory	Class II	2021-02-11	Terminated
Z-2972-2020	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.	Class II	2020-08-24	Open, Classified
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,	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 of endotoxin sufficient to produce a pyrogenic response.	Class II	2019-08-01	Open, Classified

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain