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The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
QUANTUM SURGICAL
30-0001 v1.0.2
In Commercial Distribution
- 03760305400031 ()
- Robotic surgical navigation system
The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
QUANTUM SURGICAL
09-0057
In Commercial Distribution
- 03760305400260 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
QUANTUM SURGICAL
09-0046
In Commercial Distribution
- 03760305400253 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution
- 03760305400086 ()
30-0001-01-USA
- Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution
- 03760305400062 ()
02-0027-19G
- Robotic surgical navigation system
The Patient Reference is an instrument of the EPIONE device used to track the patient
position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution
- 03760305400024 ()
02-0026
- Robotic surgical navigation system
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution
- 00860011843603 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Ezra Ai, Inc.
FLHAI01PL02IF01IT01LB02
In Commercial Distribution
- 00860010264621 ()
- Radiology DICOM image processing application software
No Description
Ezra Ai, Inc.
FLHAI00PL01IF00IT00LB01
In Commercial Distribution
- 00860010264614 ()
- Radiology DICOM image processing application software
Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing
Renalytix Ai, Inc.
RENX-3011087
In Commercial Distribution
- 00860009877931 ()
- General specimen collection kit