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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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Varex Imaging Nexus DRF Imaging Software - 00854344007269

No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007269 ()


  • X-ray system computer, diagnostic, general-purpose

Nexus DRF, Digital Imaging Software - 00854344007245

No Description
VAREX IMAGING CORPORATION
v3.1.1
In Commercial Distribution

  • 00854344007245 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor - 00854344007054

No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus, DRF, v2.5 - 00854344007023

No Description
VAREX IMAGING CORPORATION
Nexus, DRF, v2.5
In Commercial Distribution

  • 00854344007023 ()


  • X-ray system computer, diagnostic, general-purpose

Radiology Information Systems, Inc. - 00860009490604

PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation

InfiMed Nexus, DRF, v2.5 - 00858086006122

No Description
INFIMED, INC.
2.5
Not in Commercial Distribution

  • 00858086006122 ()


  • X-ray system computer, diagnostic, general-purpose

InfiMed Nexus, RF/DR, Digital Receptor - 00858086006030

No Description
INFIMED, INC.
Nexus-DRF
Not in Commercial Distribution

  • 00858086006030 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus DRF, v3.5 - 00810751030252

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose

Local Run Manager CF 139-Variant 2.0 Micro Analysis Module - 00816270020378

The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072975
In Commercial Distribution

  • 00816270020378 ()
20072975

  • Cystic fibrosis IVD, kit, multiplex

Local Run Manager CF 139 Variant Analysis Module - 00816270020286

The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay.
ILLUMINA, INC.
20047009
In Commercial Distribution

  • 00816270020286 ()
20047009

  • Cystic fibrosis IVD, kit, multiplex
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