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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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No Description
INFIMED, INC.
PlatinumOne RF
Not in Commercial Distribution

  • 00858086006047 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus-DRF
Not in Commercial Distribution

  • 00858086006030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DRF (RF/DR)
Not in Commercial Distribution

  • 00858086006023 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DR
Not in Commercial Distribution

  • 00858086006016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose
Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer’s internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT- 29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.0
In Commercial Distribution

  • 07290016836202 ()
  • 00729001683639 ()


  • CT system computer
XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT system computer
Wall Cradle, Non-Contact Therm,Acrylic w/hardware & box, RM
AMERICAN DIAGNOSTIC CORP
429CRADLE
In Commercial Distribution

  • 00634782085186 ()
429CRADLE

  • Infrared patient thermometer, skin
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