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ICU MEDICAL, INC.
2193
In Commercial Distribution
- 15019517081282 ()
21-2193-0402-25
- Infusion pump medication-dosage application software
67-2586-0100-01 is an electronic file. There is no packaging.
ICU MEDICAL, INC.
67-2586-0100-01
In Commercial Distribution
- 15019517130928 ()
- Outer Diameter: 0 Millimeter
- Length: 0 Millimeter
- Width: 0 Millimeter
- Circumference: 0 Millimeter
- 0
- Depth: 0 Millimeter
- Infusion pump medication-dosage application software
DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients.
It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.
The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution
- 05903021560742 ()
- Cardiopulmonary physiological parameter analysis software
The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution
- 05903021560131 ()
- Cardiopulmonary physiological parameter analysis software
Sleep quality and sleep disordered breathing detection from pulse oximeters.
Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
8.0
In Commercial Distribution
- 00864458000469 ()
- Sleep disorder interpretive software, professional-only
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution
- 00864458000452 ()
- Sleep disorder interpretive software, professional-only
Sleep quality and sleep disordered breathing detection from pulse oximeters.
Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
7.0
Not in Commercial Distribution
- 00864458000445 ()
- Sleep disorder interpretive software, professional-only
Client site located software application that receives IAD-generated data and provides the mechanism by which patient information is transferred to the Application Server (UltraLinq) via internet.
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
UP_001
In Commercial Distribution
- 00862894000319 ()
- Multidisciplinary medical image management software
UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLinq conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
58.13
In Commercial Distribution
- 00862894000302 ()
- Multidisciplinary medical image management software
Epicardia 5000 is a screening tool for patients who require ambulatory ECG monitoring for extended time periods.
MEDICOMP, INC.
N/A
In Commercial Distribution
- 00862887000302 ()
- Cardiology information system application software