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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The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D L CEPH L
Not in Commercial Distribution

  • D804W09002330 ()
W0900233

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH R
Not in Commercial Distribution

  • D804W09000120 ()
W0900012

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
No Description
AALTO SCIENTIFIC
K943M-5
In Commercial Distribution

  • B085K943M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K942M-5
In Commercial Distribution

  • B085K942M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K941M-5
In Commercial Distribution

  • B085K941M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K940M-5
In Commercial Distribution

  • B085K940M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K919M-5
In Commercial Distribution

  • B085K919M50 ()


  • Total bilirubin IVD, control
No Description
AALTO SCIENTIFIC
K918M-5
In Commercial Distribution

  • B085K918M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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