Product code ORR
- Device name
- Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
- Source
- FDA openFDA device classification dataset