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23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, CYP2C19 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight, BRCA1/BRCA2 (Selected Variants) report update
23ANDME, INC.
YouDot
In Commercial Distribution
- 00859462006415 ()
- Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related)
23ANDME, INC.
YouDot
Not in Commercial Distribution
- 00859462006392 ()
- Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report
23ANDME, INC.
YouDot
Not in Commercial Distribution
- 00859462006378 ()
- Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS)
Includes :
Carrier Status Report
Genetic Health Risk Reports
Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP))
Pharmacogenetics Reports
23ANDME, INC.
YouDot
Not in Commercial Distribution
- 00859462006279 ()
- Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS)
Includes :
Carrier Status Report
Genetic Health Risk Reports
Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP))
23ANDME, INC.
YouDot
Not in Commercial Distribution
- 00859462006118 ()
n/a
- Human genomic analysis interpretive software
Personal Genome Service (Genetic Reports)
23ANDME, INC.
YouDot
n/a
- Human genomic analysis interpretive software
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution
- 06945087505175 ()
- Eye anterior segment analyser
HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution
- 00724995220594 ()
XQHPILCC
- Operating room audiovisual data/device management system application software
HexaVue IP Surgical Light Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution
- 00724995220587 ()
XQHPSLC
- Operating room audiovisual data/device management system application software
The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from saliva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).
GENOMECONSULT, LLC
GlutenID
In Commercial Distribution
- 00860013485405 ()
- Human genomic analysis interpretive software
Talis EMR with +ACG is software intended to support patient care and billing documentation requirements and process control criteria defined by medical facility
Talis Clinical, LLC
Talis EMR with +ACG
In Commercial Distribution
- 00860012608805 ()
Talis EMR with +ACG
- Clinical management support software
Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors
GLOOKO, INC.
1.xx
Not in Commercial Distribution
- 00855093008040 ()
- Clinical management support software
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution
- 00855093008033 ()
- Clinical management support software
Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
xx.yy (xx is model year and yy is a serial number)
In Commercial Distribution
- 00855093008026 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution
- 00855093008019 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution
- 00860004785101 ()
- Length: 155 Millimeter
- Width: 65 Millimeter
- Height: 206 Millimeter
FIRMM®
- MRI system application software
The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC Version 8
Not in Commercial Distribution
- 00724995163723 ()
XQSLC1
- Operating room audiovisual data/device management system application software
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution
- 00882916000011 ()
- MRI system application software
The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution
- 00724995153083 ()
XQSLC1
- Operating room audiovisual data/device management system application software
OR Integration software module Version 6 that allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution
- 00724995152031 ()
- Operating room audiovisual data/device management system application software
No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution
- 05070000764122 ()
- Clinical management support software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution
- 05060878810052 ()
- Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution
- 05060878810021 ()
- Ultrasound imaging system application software
Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution
- 05415062388310 ()
- Cardiovascular interpretive screening software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution
- 00850893007033 ()
- Clinical management support software
Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007026 ()
- Clinical management support software
Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.
AMBIENT CLINICAL ANALYTICS, INC.
P1.0
In Commercial Distribution
- 00850893007019 ()
- Clinical management support software
No Description
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007002 ()
- Clinical management support software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion
Indications for use:
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution
- 05600250059022 ()
- MRI system application software
Personal Genome Service - Carrier Status Reports
23ANDME, INC.
YouDot (Carrier)
Not in Commercial Distribution
- 00862150000060 ()
- Human genomic analysis interpretive software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.4
Not in Commercial Distribution
- 00864747000262 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.3
Not in Commercial Distribution
- 00864747000255 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.2
Not in Commercial Distribution
- 00864747000248 ()
- MRI system application software
NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis.
NEOSOFT LLC
3.0.0
In Commercial Distribution
- 00864747000231 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.1
Not in Commercial Distribution
- 00864747000224 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.0
Not in Commercial Distribution
- 00864747000217 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
3.0.1
Not in Commercial Distribution
- 00864747000200 ()
- MRI system application software
No Description
CORTECHS LABS INC
LQ
In Commercial Distribution
- 00863725000317 ()
- MRI system application software