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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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XACT Robotics: Robot Drape - 07290017702094

Robot Medical Drape
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702091 ()
  • 07290017702094 ()
XR-RBT-DRP

  • Medical equipment/instrument drape, single-use

XACT Robotics: 19g Needle Threading Jig - 07290017702063

19G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702060 ()
  • 07290017702063 ()
XR-19G-IIK

  • Robotic surgical needle holder, single-use

XACT Robotics: 18g Needle Threading Jig - 07290017702056

18G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702053 ()
  • 07290017702056 ()
XR-18G-IIK

  • Robotic surgical needle holder, single-use

XACT Robotics: 17g Needle Threading Jig - 07290017702049

17G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702046 ()
  • 07290017702049 ()
XR-17G-IIK

  • Robotic surgical needle holder, single-use

XACT ACE Robot - 07290017702018

XACT ACE Robot
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702018 ()
XR-ACE-RBT

  • Robotic surgical arm system

SafeCT-29 - 07290016836202

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

uCT - 00810030350040

The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
UIH TECHNOLOGIES LLC
uCT 780
In Commercial Distribution

  • 00810030350040 ()


  • Full-body CT system

uCT - 00810030350033

The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
UIH TECHNOLOGIES LLC
uCT 760
In Commercial Distribution

  • 00810030350033 ()


  • Full-body CT system

uCT - 00810030350026

The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
UIH TECHNOLOGIES LLC
uCT 550
In Commercial Distribution

  • 00810030350026 ()


  • Full-body CT system

uCT - 00810030350019

The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
UIH TECHNOLOGIES LLC
uCT 530
In Commercial Distribution

  • 00810030350019 ()


  • Full-body CT system
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