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Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software
The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007122 ()
NA-RBT1
- Noninvasive vascular ultrasound system, line-powered
The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007115 ()
NA-DSP2
- Noninvasive vascular ultrasound support kit
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
HYLAND LLC
5.2.X
In Commercial Distribution
- 00850677007419 ()
CS.5.2
- Radiological PACS software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including
patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client
configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
- Radiological PACS software
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007389 ()
- Radiological PACS software
No Description
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007310 ()
- Radiological PACS software
Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007303 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007297 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007280 ()
- Radiological PACS software