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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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Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
ACCURAY INCORPORATED
1050242
In Commercial Distribution

  • M65810502420 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer
No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
SRS Medical Systems, Inc.
900-026
In Commercial Distribution

  • 00890477000180 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-037
In Commercial Distribution

  • 00890477000098 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
REMI 8.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1385
In Commercial Distribution

  • 00850026574722 ()


  • Robotic surgical navigation system
Aesculap Instrument Case
Fusion Robotics, LLC
1102
In Commercial Distribution

  • 00850026574715 ()


  • Robotic surgical navigation system
REMI 7.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1375
In Commercial Distribution

  • 00850026574708 ()


  • Robotic surgical navigation system
REMI 6.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1365
In Commercial Distribution

  • 00850026574692 ()


  • Robotic surgical navigation system
REMI 5.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1355
In Commercial Distribution

  • 00850026574685 ()


  • Robotic surgical navigation system
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