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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution

  • 00867170000106 ()


  • MRI system application software
No Description
VERATHON INC
QuickPrint
In Commercial Distribution

  • 00879123006134 ()
0900-1238

  • Ultrasound imaging system application software
No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software
No Description
VERATHON INC
ScanPoint Local Client
In Commercial Distribution

  • 00879123004239 ()
0900-1009

  • Ultrasound imaging system application software
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
MELLITUS HEALTH, INC.
Version 1
In Commercial Distribution

  • 00860001009804 ()


  • Clinical management support 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, SLCO1B1 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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006408 ()


  • 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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006385 ()


  • 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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006262 ()


  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports BRCA1/BRCA2 (Selected Variants)
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006095 ()
n/a

  • Human genomic analysis interpretive software
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