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PeriWatch Vigilance 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
2024.2.xxx
In Commercial Distribution
- B087CURV202421 ()
- 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
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution
- B202BCSEG0 ()
BCSEG
- Bioelectrical signal analysis software
No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution
- B202BC0 ()
BC
- Bioelectrical signal analysis software
No Description
OTOHARMONICS CORPORATION
PATIENT
In Commercial Distribution
- B400215930 ()
- Tinnitus masking application software
No Description
OTOHARMONICS CORPORATION
MANAGER
In Commercial Distribution
- B400215720 ()
- Tinnitus masking application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. 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 blood pressure monitors, activity trackers, and weight scales as well as self reported health information. The software provides educational content to encourage behaviors which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining 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
In Commercial Distribution
- B553202195OTC0 ()
- Medication reminder application software