# K162314: IMACTIS CT-Navigation system

- Pathway: 510(k) (Traditional)
- Applicant: Imactis, Sas
- Decided: Apr 24, 2018 after 614 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911783 (1994). 53 ancestors in all.
No later device cites it as a predicate yet.
6 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151414: IQQA Guide, Edda Technology (2015) Summary page 4.

## Recalls of this device
- Feb 3, 2026 · Class II · Z-1590-2026: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- Feb 11, 2021 · Class II · Z-1264-2021: 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 be
- Aug 24, 2020 · Class II · Z-2972-2020: 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 ina
- Aug 1, 2019 · Class II · Z-0838-2020: 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 prod

## Indications for use
The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space. The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures. The system is not intended for guidance for the head, neck, central nervous system and central circulatory system (heart included).

Source page: https://510kreport.com/device/K162314
Methodology: https://510kreport.com/methodology