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Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
Tempus AI, Inc.
2
In Commercial Distribution
- 00860011843610 ()
- Cardiopulmonary physiological parameter analysis software
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution
- 00763000504533 ()
- Implantable cardiac device management application software
SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution
- 00763000504526 ()
- Implantable cardiac device management application software
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 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
Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution
- 05060434420008 ()
51-000001-00
- Extracorporeal blood gas/pH monitor
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution
- 00860010168417 ()
- Endoscopic video image interpretive unit