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PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.06.00
In Commercial Distribution
- B087CURV02061 ()
- Obstetrical monitoring/analysis software
The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.8
In Commercial Distribution
- B057U40140 ()
U4 014
- Stereotactic system application software
The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.17
In Commercial Distribution
- B057U4003260170 ()
U4 003
- Stereotactic system application software
The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.16
In Commercial Distribution
- B057U4003260160 ()
U4 003
- Stereotactic system application software
The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.15
In Commercial Distribution
- B057U40030 ()
U4 003
- Stereotactic system application software
No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution
- B006EMGVIEW0 ()
- Bioelectrical signal analysis software
No Description
THINK SURGICAL, INC.
109939
In Commercial Distribution
- M9461099390 ()
109939
- Stereotactic system application software
No Description
THINK SURGICAL, INC.
109000
In Commercial Distribution
- M9461090000 ()
109000
- Stereotactic system application software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient 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 HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
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. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions 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
In Commercial Distribution
- B553202303OTC0 ()
- Self-care monitoring/reporting software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient 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 HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
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. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions 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
In Commercial Distribution
- B553202302OTC0 ()
- Self-care monitoring/reporting software