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.
| Device Type ID | 4126 |
| Device Name | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NRZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4126 |
| Device | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Product Code | NRZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 2 |
| Total Device Problems | 2 |