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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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UltraSPECT - 00850040177084

WBR Imaging X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177084 ()


  • SPECT system application software

UltraSPECT - 00850040177077

WBR Imaging X + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177077 ()


  • SPECT system application software

UltraSPECT - 00850040177060

WBR Imaging X + X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177060 ()


  • SPECT system application software

UltraSPECT - 00850040177053

WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software

UltraSPECT - 00850040177046

WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software

UltraSPECT - 00850040177039

WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software

UltraSPECT - 00850040177022

WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software

UltraSPECT - 00850040177015

WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software

UltraSPECT - 00850040177008

WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software

Cydar EV - 05060508110002

The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set. Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution

  • 05060508110002 ()


  • Angiographic x-ray system application software
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