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Programmer System
CVRX, INC.
9010
In Commercial Distribution
- 00859144004128 ()
100055-102
- Baroreceptor electrical stimulation system
AURA™ Data Receiver Pack
Branchpoint & Aura Development LLC
DG101
In Commercial Distribution
- 00860011785224 ()
DG101
- Medical networking interface unit
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
The VU system provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure which substantially reduces the risk of pressure injuries. This variant for narrow format hospital beds.
Wellsense, Inc.
WS-MAT-200-06
In Commercial Distribution
- 00860009142923 ()
- Body-surface pressure mapping system
The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries. This product version is designed for use on bariatric beds / patients.
Wellsense, Inc.
WS-MAT-200-04
In Commercial Distribution
- 00860009142916 ()
- Body-surface pressure mapping system
The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries.
Wellsense, Inc.
WS-MAT-200-02
In Commercial Distribution
- 00860009142909 ()
- Body-surface pressure mapping system
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution
- 00860003118368 ()
- Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution
- 00860003118313 ()
- Medical networking interface unit
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution
- 00860006137014 ()
- Medical networking interface unit
Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution
- 00860003252543 ()
- 00860008537805 ()
- Intraoperative tumour margin fluorescence imaging system