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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MDNC-3421 DE MKII
Barco NV
mdnc-3421
In Commercial Distribution

  • 05415334028326 ()
K9300346B

  • Radiology picture archiving and communication system workstation
HMD Custom Lens Insert
Sentiar, Inc.
RXL01
In Commercial Distribution

  • 00850013331079 ()


  • Radiology picture archiving and communication system workstation
HMD
Sentiar, Inc.
HMD02
In Commercial Distribution

  • 00850013331048 ()


  • Radiology picture archiving and communication system workstation
HMD
Sentiar, Inc.
HMD01
In Commercial Distribution

  • 00850013331031 ()


  • Radiology picture archiving and communication system workstation
Enclosure
Sentiar, Inc.
ENC01
In Commercial Distribution

  • 00850013331024 ()


  • Radiology picture archiving and communication system workstation
Data Manager PC
Sentiar, Inc.
DPC01
In Commercial Distribution

  • 00850013331017 ()


  • Radiology picture archiving and communication system workstation
Data Manager PC
Sentiar, Inc.
DPC02
In Commercial Distribution

  • 00850013331000 ()


  • Radiology picture archiving and communication system workstation
No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation
The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Radiopharmaceutical Imaging and Dosimetry, LLC
3DRD-001
In Commercial Distribution

  • 00860009926905 ()


  • Nuclear medicine system workstation
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.
Hermes Medical Solutions AB
7.0
In Commercial Distribution

  • 00859873006189 ()
P31

  • Nuclear medicine system workstation
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