Artemis with ProFuse
Basic Information
- Brand Name
- Artemis with ProFuse
- Primary DI
- 00860009734838
- Version / Model
- 2.0 HD
- Catalog Number
- 900-20000-01
- Company Name
- Eigen Health Services LLC
- Labeler DUNS
- 117062155
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 2
- Public Version Date
- 2026-01-29
- Public Version Status
- Update
- Public Device Record Key
- 0f62643b-d66d-4364-97df-fff4611c3e07
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60656 | Rectal ultrasound navigational image processor | A mobile, mains electricity (AC-powered) device intended to be used in conjunction with an ultrasound imaging system and rectal ultrasound transducer to display two- and three-dimensional (3-D) ultrasound images of tissues (e.g., the prostate). It consists of a personal computer (PC) based workstation which processes data from the ultrasound imaging system, and a mechanical assembly intended to mount and track the rectal ultrasound transducer to generate a real-time 3-D image. Depending on specific software, packages may also allow for biopsy navigation and further image processing/data management. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009734838 | GS1 |