Definition: For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia.
| Device Type ID | 5478 |
| Device Name | Tracking, Soft Tissue, Intraoperative |
| Physical State | A PC With LCD Monitor For Displaying Images, Tracked Laser Range Scanner, Tracked Fixed Reference Emitter, Tracked Localization Probe With Infrared Emitting Dioodes, And Three Lens Active-based Optical Position Sensor |
| Technical Method | The Device Uses Optical, Infrared Light Tracking Systems For Localizing Surgical Tools And A Camera For Spatial Reconstruction Of Tool Alignment And Position |
| Target Area | Soft Tissue |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| 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 | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5478 |
| Device | Tracking, Soft Tissue, Intraoperative |
| Product Code | OEW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |