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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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Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data. Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images. Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
Olea Medical USA
1.5
In Commercial Distribution

  • EOLEAUTOMATIONV1P50 ()


  • Radiological PACS software
For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files
Radiology Information Systems, Inc.
RSVS
In Commercial Distribution

  • 00860009490642 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system digital archive device
BD FACS™ Sample Prep Assistant III Software v6.0
Becton, Dickinson And Company
664116
In Commercial Distribution

  • 00382906641168 ()
664116

  • Laboratory analyser operation system software IVD
No Description
Roche Diagnostics GmbH
09891986001
In Commercial Distribution

  • 07613336223321 ()
09891986001

  • Clinical management support software IVD
No Description
Aesku.Diagnostics GmbH & Co. KG
REF.HER-1000
In Commercial Distribution

  • 04250289512909 ()


  • Clinical management support software IVD
Rail Tray - Dual Track Rail Caddy
ORTHOPEDIATRICS CORP.
01-2200-0105
In Commercial Distribution

  • 00841132178799 ()
01-2200-0105

  • External orthopaedic fixation frame calculation software
Rail Tray - Wire Caddy
ORTHOPEDIATRICS CORP.
01-2200-0104
In Commercial Distribution

  • 00841132178775 ()
01-2200-0104

  • External orthopaedic fixation frame calculation software
Rail Tray - Half Pin Caddy
ORTHOPEDIATRICS CORP.
01-2200-0103
In Commercial Distribution

  • 00841132178720 ()
01-2200-0103

  • External orthopaedic fixation frame calculation software
Rail Tray - Lid
ORTHOPEDIATRICS CORP.
01-2200-0102
In Commercial Distribution

  • 00841132178706 ()
01-2200-0102

  • External orthopaedic fixation frame calculation software
Rail Tray - Base
ORTHOPEDIATRICS CORP.
01-2200-0101
In Commercial Distribution

  • 00841132178683 ()
01-2200-0101

  • External orthopaedic fixation frame calculation software
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