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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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Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
No Description
Drägerwerk AG & Co. KGaA
MS17277
Not in Commercial Distribution

  • 04048675053682 ()


  • Desktop computer
Chromebook for Arial Web Client Only
Securitas Healthcare LLC
54385
In Commercial Distribution

  • 00840948103025 ()
54385

  • Desktop computer
Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
Arial U Client PC
Securitas Healthcare LLC
56111
In Commercial Distribution

  • 00840948101076 ()


  • Desktop computer
TOWER, CONFIGURED, WIN 10, 64 BIT, ARIAL CLIENT
Securitas Healthcare LLC
0900-696
In Commercial Distribution

  • 00840948100994 ()


  • Desktop computer
Arial Tower, Configured, Arial Client
Securitas Healthcare LLC
0900-652
In Commercial Distribution

  • 00840948100833 ()


  • Desktop computer
SOMNOSTAR 11 UPGRADE
Carefusion Corporation
29675-001
Not in Commercial Distribution

  • 10846446033298 ()
29675-001

  • Desktop computer
OPTIPLEX XE2 WIN7 64BIT ENGLISH 100_240V (VMAX)
Carefusion Corporation
26751-307
Not in Commercial Distribution

  • 10846446026443 ()
26751-307

  • Desktop 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
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