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Optum Home BP I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
UA651BLE
Not in Commercial Distribution
- 00862492000339 ()
AAA-80013
- Self-care monitoring/reporting software
Optum Home Scale I-ICUE
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution
- 00862492000322 ()
AAA-85009
- Self-care monitoring/reporting software
Optum Home Scale I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution
- 00862492000315 ()
AAA-80012
- Self-care monitoring/reporting software
The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments.
The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
SANITAS, INC.
Version 3.0 Released 20160615
Not in Commercial Distribution
- 00860508000311 ()
- Self-care monitoring/reporting software
Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:
+ Health behaviors (e.g., smoking and exercise);
+ Screening tests (e.g., blood cholesterol and mammography);
+ Health history among his or her first- and second-degree relatives.
One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages.
The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.
SANITAS, INC.
Version 2.0 Released 20160615
Not in Commercial Distribution
- 00860508000304 ()
- Self-care monitoring/reporting software
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst
stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing
or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos
deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Vitrolife A/S
16531
In Commercial Distribution
- 05712714675317 ()
16531
- Assisted reproduction embryo-assessment software
ACC SOUNDCONNECT LANG PACK_1
Widex A/S
ACC SOUNDCONNECT LANG PACK_1
In Commercial Distribution
- 05714880213270 ()
8 928 0100 000
- Audiometric/hearing device software
Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution
- 05714880199420 ()
21026345
- Audiometric/hearing device software
Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution
- 05714880189308 ()
21022296
- Audiometric/hearing device software
APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution
- 05714880187229 ()
21023158
- Audiometric/hearing device software
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution
- 00860012940608 ()
- Virtual-display routine exercise software
The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.
Earlitec Diagnostics, Inc.
EPT001
In Commercial Distribution
- 00860009993709 ()
- Neurodevelopmental disorder interpretive software
Medical Device Data Systems (MDDS)
Veris Health Inc.
Veris Health Platform
In Commercial Distribution
- 00860009591004 ()
- Self-care monitoring/reporting software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution
- 00300021107550 ()
MA7723001AM
- Medication reminder application software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution
- 00300021109554 ()
MA9131001AM
- Medication reminder application software
BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution
- 00199284085701 ()
BCL-MS
- Self-care monitoring/reporting software
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution
- 00195949116209 ()
- Self-care monitoring/reporting software
Sleep Apnea Notification Feature WatchOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution
- 00195949116193 ()
- Self-care monitoring/reporting software
Polysomnography Sleep System Version 11
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-11X
In Commercial Distribution
- 00841983104008 ()
A/ONEBED-SCORE-11X
- Sleep disorder interpretive software
LibreLinkUp
ABBOTT DIABETES CARE INC
72154-01
In Commercial Distribution
- 00357599824006 ()
72154-01
- Self-care monitoring/reporting software