510(k) K171257
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2017
- Date Received
- April 28, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.