Definition: To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An MRI Suite.
| Device Type ID | 3775 |
| Device Name | Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Physical State | Software: Aquire MR Images, Trajectory Planning, Guidance Regarding Alignment Of Targeting Frame With Planned Trajectory, Confirmation Of Final Tool Position (MR Compatible Tools Only). Hardware: Stereotaxic Frame And Accessories (e.g. Various Diamet |
| Technical Method | Device Software Receives Real-time, Intraoperative MR Images Of The Brain Target And The Trajectory Of The Targeting Frame Attached To The Patient's Skull. Software And MRIs Are Used To Plan Trajectory, Guide Alignment Of Frame With Planned Trajector |
| Target Area | Skull And Brain |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3775 |
| Device | Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Product Code | ORR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MRI INTERVENTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Human-Device Interface Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |