• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device mr-guided focused ultrasound system
Definition An mr-guided focused ultrasound system is intended to use high intensity focused ultrasound (hifu) to heat and ablate soft tissue in the brain to treat neurological disorders.Mr imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.
Physical State Transducer Array, Computer Workstation, Water Chiller, MR Table
Technical Method Device uses high frequency ultrasound to heat and ablate soft tissue.
Target Area Brain
Review Panel Neurology
Product CodePOH
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-