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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 Class Implantable

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vRad PACS - 00862234000306

vRad PACS 1
Vrad
1
In Commercial Distribution

  • 00862234000306 ()


  • Radiological PACS software

PicomEnterprise - 00861917000305

No Description
SCIMAGE, INC
3.x
In Commercial Distribution

  • 00861917000305 ()


  • Radiological PACS software

Simpleware ScanIP Medical - 00863520000383

No Description
SYNOPSYS, INC.
R-2021.03
Not in Commercial Distribution

  • 00863520000383 ()


  • Radiological PACS software

Synopsys Simpleware ScanIP - 00863520000338

No Description
SYNOPSYS, INC.
O-2018.12
Not in Commercial Distribution

  • 00863520000338 ()


  • Radiological PACS software

Smart Stitching - 00869126000451

A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review.
OSKO, INC.
Smart Stitching
In Commercial Distribution

  • 00869126000451 ()


  • Radiological PACS software

VidiStar PACS & DICOM Viewer Software - 00869047000431

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
Fujifilm Healthcare Americas Corporation
4.X.X
In Commercial Distribution

  • 00869047000431 ()


  • Radiological PACS software

InTouch Health - 00868772000174

No Description
INTOUCH TECHNOLOGIES, INC.
InTouch Imaging
In Commercial Distribution

  • 00868772000174 ()


  • Radiological PACS software

Dentrix Ascend Imaging - 00864058000302

Web-based dental Picture Archiving and Communications System (PACS)
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000302 ()


  • Radiological PACS software

eRAD PACS - 00866994000255

eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software

eRAD PACS Evolution - 00866994000224

eRAD PACS Evolution
Erad, Inc.
8.0
In Commercial Distribution

  • 00866994000224 ()


  • Radiological PACS software
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