Product Classification

• Device: ablation system, high intensity focused ultrasound (hifu), mr-guided
• Definition: An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
• Review Panel: Obstetrics/Gynecology
• Product Code: NRZ
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-280 IEC 62555 Edition 1.0 2013-11
  Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
• 12-281 IEC 60601-2-62 Edition 1.0 2013-07
  Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Third Party Review

Not Third Party Eligible