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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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Merge Cardio - 00842000100416

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100416 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100409

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100409 ()


  • Radiology picture archiving and communication system workstation

Merge Cardio - 00842000100065

No Description
MERGE HEALTHCARE SOLUTIONS INC.
12.2
In Commercial Distribution

  • 00842000100065 ()


  • Radiology picture archiving and communication system workstation

Xeleris Processing and Review Workstation - 00195278245021

Xeleris V Clinical Application SW
G E MEDICAL SYSTEMS ISRAEL LTD.
V
In Commercial Distribution

  • 00195278245021 ()


  • Nuclear medicine system workstation

ASPIRE Bellus II - 04547410345438

ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.
FUJIFILM CORPORATION
MIS-1000
In Commercial Distribution

  • 04547410345438 ()


  • Radiology picture archiving and communication system workstation

Synapse 3D - 04547410324877

The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331079

HMD Custom Lens Insert
Sentiar, Inc.
RXL01
In Commercial Distribution

  • 00850013331079 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331048

HMD
Sentiar, Inc.
HMD02
In Commercial Distribution

  • 00850013331048 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331031

HMD
Sentiar, Inc.
HMD01
In Commercial Distribution

  • 00850013331031 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331024

Enclosure
Sentiar, Inc.
ENC01
In Commercial Distribution

  • 00850013331024 ()


  • Radiology picture archiving and communication system workstation
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