Definition: As An Adjunctive Tool To Guide The Shavings Of Tissue At The Margins Of The Tumor For Use In Excisional Breast Surgery To Assist In Locating The Tissue For Excision. In Addition To Other Standard Methods Such As Intraoperative Imaging And Palpation.
| Device Type ID | 5957 |
| Device Name | Diagnostic Low Electric Field |
| Physical State | Low Electromagnetic Field |
| Technical Method | It Utilizes Electromagnetic Waves To Characterize Human Tissue In Real-time. It Consists Of A Console And A Disposable Hand-piece. |
| Target Area | Breast Tumor |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OEE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5957 |
| Device | Diagnostic Low Electric Field |
| Product Code | OEE |
| FDA Device Classification | Class 3 Medical Device |