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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.
Eigen Health Services LLC
2.0 HD
In Commercial Distribution
- 00860009734838 ()
- Rectal ultrasound navigational image processor
Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution
- 00851800007092 ()
Visix for Intraoral Camera 2.3.10
- Camera application software
- Radiological PACS software
Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)
Nihon Kohden Digital Health Solutions, LLC
CGS-9001
In Commercial Distribution
- 00851725007092 ()
CGS-9001
- Medical networking interface unit
ZEROWIRE TX, DVI, SDI, W/ACCESSORIES, SINGLE CHANNEL, CHINA, WT-P11-13
Nds Surgical Imaging LLC
90T0033
Not in Commercial Distribution
- 00851455007256 ()
- Medical networking interface unit
ZEROWIRE RX, DVI, W/ACCESSORIES, SINGLE CHANNEL, CHINA, WR-P11-11
Nds Surgical Imaging LLC
90T2032
Not in Commercial Distribution
- 00851455007249 ()
- Medical networking interface unit
External Syncing Unit - Multi-Channel Kit (PAN 1026A)
ADVANCED BRAIN MONITORING, INC.
ES31-1001, ES31-1003
In Commercial Distribution
- 00851113007918 ()
- 00851113007901 ()
- Medical networking interface unit
Bluetooth Dongle - PAN 1026
ADVANCED BRAIN MONITORING, INC.
31-1003, 31-1004
In Commercial Distribution
- 00851113007833 ()
- Medical networking interface unit
External Syncing Unit - Multi-Channel Kit
ADVANCED BRAIN MONITORING, INC.
ES31-1001, ES31-1003
In Commercial Distribution
- 00851113007406 ()
- 00851113007475 ()
- Medical networking interface unit
Bluetooth Dongle
ADVANCED BRAIN MONITORING, INC.
31-1003
In Commercial Distribution
- 00851113007260 ()
- Medical networking interface unit
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution
- 00860003118368 ()
- Medical networking interface unit