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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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Tipso Airpad (A wireless controller)
NZ Technologies Inc
APAD-APL2
In Commercial Distribution

  • 07540293000002 ()


  • Computer mouse/roller-ball
XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT 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
Transducer Cable
ST. JUDE MEDICAL, INC.
C12683
In Commercial Distribution

  • 05415067010667 ()
C12683

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12682
In Commercial Distribution

  • 05415067010650 ()
C12682

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12681
In Commercial Distribution

  • 05415067010643 ()
C12681

  • Electrical-only medical device connection cable, reusable
Transducer Cable
ST. JUDE MEDICAL, INC.
C12680
In Commercial Distribution

  • 05415067010636 ()
C12680

  • Electrical-only medical device connection cable, reusable
Monitor Cable
ST. JUDE MEDICAL, INC.
C12908
In Commercial Distribution

  • 05415067006615 ()
C12908

  • Electrical-only medical device connection cable, reusable
Monitor Cable
ST. JUDE MEDICAL, INC.
C12960
In Commercial Distribution

  • 05415067006608 ()
C12960

  • Electrical-only medical device connection cable, reusable
Monitor Cable
ST. JUDE MEDICAL, INC.
C12924
In Commercial Distribution

  • 05415067006592 ()
C12924

  • Electrical-only medical device connection cable, reusable
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