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 Type ID | 3867 |
| Device Name | Mr-guided Focused Ultrasound System |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | POH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3867 |
| Device | Mr-guided Focused Ultrasound System |
| Product Code | POH |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
No Apparent Adverse Event | 3 |
Use Of Device Problem | 2 |
| Total Device Problems | 8 |