Definition: An Imaged-Guided Focused Ultrasound System Is Intended To Use High Intensity Focused Ultrasound (HiFU) To Heat And Ablate Soft Tissue.
| Device Type ID | 5965 |
| Device Name | Ablation System, High Intensity Focus Ultrasound (hifu), Soft Tissue |
| Physical State | Transducer Array, Computer Workstation, Water Chiller, Image Table. |
| Technical Method | An Imaged-Guided Focused Ultrasound System Is Intended To Device Uses High Frequency Ultrasound To Heat And Ablate Soft Tissue. |
| Target Area | Soft Tissue. |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PZC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5965 |
| Device | Ablation System, High Intensity Focus Ultrasound (hifu), Soft Tissue |
| Product Code | PZC |