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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RADSpa RIS-PACS
TELERAD TECH PRIVATE LIMITED
RADSpa RIS-PACS 4.0
In Commercial Distribution

  • 08908008302008 ()


  • Radiology picture archiving and communication system workstation
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
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
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
TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 53S
In Commercial Distribution

  • 00850059977415 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation
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