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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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Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution

  • 00867170000106 ()


  • MRI system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
Proscia Inc.
4.6
In Commercial Distribution

  • 00860006054557 ()
US

  • Laboratory instrument/analyser application software IVD
Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Proscia Inc.
4.5
In Commercial Distribution

  • 00860006054519 ()
US

  • Laboratory instrument/analyser application software IVD
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, 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, 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, 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, NonSyndromic Hearing Loss Carrier Status Report
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006378 ()


  • Human genomic analysis interpretive software
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