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X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution
- 05415067051127 ()
ENSITE-DWS-3.1
- Cardiac mapping system
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion
Indications for use:
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution
- 05600250059022 ()
- MRI system application software
No Description
Philips North America LLC
Surveillance Monitoring System Software
In Commercial Distribution
- 00854709006074 ()
- Centralized patient monitor
No Description
Philips North America LLC
Bernoulli One Software
In Commercial Distribution
- 00854709006029 ()
- Centralized patient monitor
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution
- 00854344007658 ()
- Angiographic x-ray system application software
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution
- 00860011391500 ()
- 00860011391517 ()
- Length: 3.3 Inch
1001
- Wearable multiple vital physiological parameter monitoring system
No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution
- 00860011175803 ()
- Radiology information system
Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The
purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images.
Vitazi.Ai, Inc.
0.0.8
In Commercial Distribution
- 00860012221608 ()
- Medical image management system
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution
- 00860010575307 ()
- Ultrasound imaging system application software
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution
- 00860008932204 ()
- Wearable multiple vital physiological parameter monitoring system
MD52 Rx device
Amimon Inc.
MD52 Rx device - MDWL2_B3P1RX
In Commercial Distribution
- 00860014100673 ()
MDWL2_B3P1RX
- Medical image management system
MD52 Tx device
Amimon Inc.
MD52 Tx device - MDWL2_B1P1TX
In Commercial Distribution
- 00860014100666 ()
MDWL2_B1P1TX
- Medical image management system
MD11 Rx device
Amimon Inc.
MD11 Rx device - MDWL1_B1N1RX
In Commercial Distribution
- 00860014100635 ()
MDWL1_B1N1RX
- Medical image management system
MD11 Tx device
Amimon Inc.
MD11 Tx device - MDWL1_C1N1TX
In Commercial Distribution
- 00860014100628 ()
MDWL1_C1N1TX
- Medical image management system
MD62 Rx device
Amimon Inc.
MD62 Rx device - MDWL2_B1J1RX
In Commercial Distribution
- 00860014100611 ()
MDWL2_B1J1RX
- Medical image management system
MD62 Tx device
Amimon Inc.
MD62 Tx device - MDWL2_B1J1TX
In Commercial Distribution
- 00860014100604 ()
MDWL2_B1J1TX
- Medical image management system
MRI Monitor Remote Base/Charger
IRADIMED CORP.
3885B
In Commercial Distribution
- 00856038001218 ()
3885B
- Centralized patient monitor
No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution
- 00855778005364 ()
10A1088
- Wearable multiple vital physiological parameter monitoring system
No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution
- 00855778005463 ()
10A1112
- Wearable multiple vital physiological parameter monitoring system
No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution
- 00855778005456 ()
10A1107
- Wearable multiple vital physiological parameter monitoring system