Artemis, Artemis TPO, Artemis MX
Eigen
EIGEN
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2937707 | 2937707 | EIGEN | 1 | N | 2026-01-01 | 13366 Grass Valley Ave, Suite A Grass Valley CA US 95945 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 8305 | 1956506590 | K222222 | Artemis, Artemis TPO, Artemis MX | QTZ | 2023-10-12 |
| 8305 | 1009924263 | K173744 | ProFuse CAD | LLZ | 2018-11-21 |
| 8305 | 1214633760 | K162474 | Artemis | LLZ | 2016-10-21 |
| 8305 | 1133281968 | K120187 | MULTI-MODALITY IMAGE FUSION | LLZ | 2012-04-06 |
| 8305 | 1328861736 | K081093 | 3-D IMAGING WORKSTATION | LLZ | 2008-05-01 |
Product Codes Associated With Registrations#
PMN#
ProFuse CAD
Eigen
Artemis
EIGEN
DSA 2000EX
Eigen, LLC
3-D IMAGING WORKSTATION
EIGEN LLC
EIGEN DSA 2000
EIGEN
DIGITAL MEDIA CONVERTER (D-MC)
EIGEN VIDEO
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
EIGEN VIDEO
DIGITAL DISK RECORDER
EIGEN
DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
EIGEN
DIGITAL FLUORO STORE
EIGEN
DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
EIGEN
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
EIGEN
PSC-1 W/OTHER NUMERICAL
EIGEN
DIGITAL PHOTOSPOT
EIGEN
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
EIGEN
SC-1000 WITH SUFFIXES (SCAN CONVERTER)
EIGEN
HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP
EIGEN
VTR-12
EIGEN
HR-1000 W/SUFFIXES (B,C OR D)
EIGEN
DIGITAL IMAGE PROCESSOR FP-2C
EIGEN VIDEO
EIGEN FLORO-STOR FS-100
EIGEN VIDEO
GUDID#
Artemis-TPOS - 3D workstation for transperineal only biopsy navigation and planning of the prostate.
2026-01-28
Artemis - 3D workstation for Transrectal/transperineal biopsy navigation and planning of the prostate.
2026-01-28
ProFuse - MRI annotation and analysis tool
2026-01-28
Artemis with ProFuse - 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.
2024-12-20