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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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REAL INTELLIGENCE ROBOTICS CART BASE 120
Smith & Nephew, Inc.
ROB100021
In Commercial Distribution

  • 00885556774144 ()
ROB100021

  • Optical surgical navigation device tracking system workstation, mobile
REAL INTELLIGENCE ROBOTICS CART COLUMN
Smith & Nephew, Inc.
ROB10002
In Commercial Distribution

  • 00885556756249 ()
ROB10002

  • Optical surgical navigation device tracking system workstation, mobile
Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1064270
In Commercial Distribution

  • M65810642700 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1) The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1061799
In Commercial Distribution

  • M65810617990 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer
Software, Version 1.1.1, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution

  • M65810550960 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer
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
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
Robotic Arm & Accessories
Microport Navibot International LLC
10008NBSUB
In Commercial Distribution

  • 00850030914026 ()
10008NBSUB

  • Robotic surgical navigation system
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