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Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202201OTC0 ()
- Medication reminder application 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
In Commercial Distribution
- B553202258OTC0 ()
- Self-care monitoring/reporting software
No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution
- B006EMGVIEW0 ()
- Bioelectrical signal analysis 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
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
icometrix NV
1.1
In Commercial Distribution
- B621ICOBRAINARIA1X1Y0 ()
- Radiology DICOM image processing application software
CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINA-ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring
AVICENNA.AI
1.5
In Commercial Distribution
- B826CINAASPECTS150 ()
- Radiology DICOM image processing application software
Premier Heart MCG Analysis Cluster software, including:
- MCG Clinical Client (reference implementation and API)
- MCG Webapps/Report Generator
- MCG Clinical Database
- MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution
- B320MCGC0 ()
- Cardiopulmonary physiological parameter analysis software
No Description
HELENA LABORATORIES CORPORATION
1678000
In Commercial Distribution
- M52516780000 ()
- Densitometry analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1673000
In Commercial Distribution
- M52516730000 ()
- Densitometry analyser IVD
No Description
BTL INDUSTRIES LIMITED
BTL-995-rTMS
In Commercial Distribution
- B108995PORTMSMUS00 ()
- Magnetic neural stimulation system