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ABBOTT DIABETES CARE INC
72156-01
In Commercial Distribution
- 00357599823009 ()
72156-01
- Self-care monitoring/reporting software
MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278560384 ()
5919805
- CT system application software
No Description
Siemens Healthcare GmbH
11665508
In Commercial Distribution
- 04056869973371 ()
- Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11665278
Not in Commercial Distribution
- 04056869955667 ()
- Radiology DICOM image processing application software
Ai-Rad Companion Organs RT About Box
Siemens Healthcare GmbH
11545290
In Commercial Distribution
- 04056869274645 ()
- Radiology DICOM image processing application software
- Radiological PACS software
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution
- 03760408001005 ()
- Pathology information system
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.
3.X
Not in Commercial Distribution
- B553202257OTC0 ()
- 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.
v2.X
Not in Commercial Distribution
- B553202057OTC0 ()
- Self-care monitoring/reporting software