# K162474: Artemis

- Pathway: 510(k) (Traditional)
- Applicant: Eigen
- Decided: Oct 21, 2016 after 45 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081093: 3-D Imaging Workstation, Eigen, LLC (2008) Summary page 4.
- K153073: UroNav (Version 2.0), Invivo Corporation (2015) Summary page 4.

## Most influential descendants
- K221499: Minimally Invasive Prostate Surgery Navigation System (2022), 1 descendant of its own
- K242314: Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2) (2025), 0 descendants of its own
- K222222: Artemis, Artemis TPO, Artemis MX (2023), 0 descendants of its own

## Indications for use
Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

Source page: https://510kreport.com/device/K162474
Methodology: https://510kreport.com/methodology