ORR
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA definition
- To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ClearPoint System (K181195) | Mri Interventions, Inc. | 2018-11-02 |
| ClearPoint System (K171257) | Mri Interventions, Inc. | 2017-10-20 |
| SURGIVISION INC. CLEARPOINT SYSTEM (K111073) | Surgi-Vision, Inc. | 2011-06-22 |
| CLEARPOINT SYSTEM (K100836) | Surgivision, Inc. | 2010-06-16 |
Track ORR automatically
Every clearance here is in the API, with alerts when new ones post.