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Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution
- B236SMG6300 ()
- Human genomic analysis interpretive software
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution
- B201CGONE1 ()
- B201CGONE0 ()
- Ultrasound imaging system application software
LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician.
LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.
The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.
Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy.
Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
PERSPECTUM LTD
2.0
In Commercial Distribution
- B554LMS2000 ()
- MRI system application software
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
SWEETSPOT DIABETES CARE, INC.
350-0010
Not in Commercial Distribution
- B059POW3500010 ()
350-0010
- Noninvasive interstitial fluid glucose monitoring device
Dexcom CLARITY software, web-based data management product is intended
for use by both patients and healthcare professionals to assist people with diabetes in the
review, analysis and evaluation of historical CGM data to support effective diabetes
management. It is intended for use as an accessory to CGM devices with data interface
capabilities.
With RCP, it provides additional administrative features for use by Clinicians to
access Dexcom CLARITY reports (digital or print) for their patients with diabetes. These
features do not change the intended use of CLARITY. They improve the usefulness of it from
the clinician perspective.
SWEETSPOT DIABETES CARE, INC.
350-0011
Not in Commercial Distribution
- B059CLARITY35000011 ()
350-0011
- Noninvasive interstitial fluid glucose monitoring device
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution
- B553202057OTC0 ()
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202257OTC0 ()
- Self-care monitoring/reporting software
Software, TomoApps, Version 5.1.2
Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution
- M65810604640 ()
NA
- Linear accelerator system
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution
- B440HVCP030 ()
HVCP
- MRI system operator console
- MRI system operation software
- MRI system application software