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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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Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their results.
AIDOC MEDICAL LTD
3.x.y
In Commercial Distribution

  • 07290018052198 ()


  • Radiology DICOM image processing application software
Cenova™ image analytics server is a high-performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images.
Hologic, Inc.
Cenova Server
Not in Commercial Distribution

  • 15420045507395 ()
SW-06075

  • Radiology DICOM image processing application software
Symmetry® Hook, Shea Stapes, 20° Angle, 0.5 mm
SYMMETRY SURGICAL INC.
62-0445
In Commercial Distribution

  • 00887482040355 ()

  • Angle: 20 degree
  • Width: 0.5 Millimeter
62-0445

  • Robotic surgical navigation system application software
No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515369 ()


  • Radiology DICOM image processing application software
No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515345 ()


  • Radiology DICOM image processing application software
Rx Imola is an automated clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4900
In Commercial Distribution

  • 05055273206104 ()
RX4900

  • Multiple clinical chemistry analyser IVD, laboratory
RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX3900
In Commercial Distribution

  • 05055273205893 ()
RX3900

  • Multiple clinical chemistry analyser IVD, laboratory
Grid 3D Image Distortion Analysis System- Includes One Phantom and 2 software licenses..
Modus Medical Devices Inc
100-1017
In Commercial Distribution

  • G34310010170 ()


  • Multi-modality therapeutic radiation phantom, test object
LCD touch screen recording system with HDMI loop through. Software version update 1.7.14
Nds Surgical Imaging LLC
Evo4K130
Not in Commercial Distribution

  • 00817613020857 ()


  • Endoscopic video image processing unit
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