ORR · Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | ORR |
|---|---|
| Device Name | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181195 | ClearPoint System | Mri Interventions, Inc. | Nov 2, 2018 | SESE |
| K171257 | ClearPoint System | Mri Interventions, Inc. | Oct 20, 2017 | SESE |
| K111073 | SURGIVISION INC. CLEARPOINT SYSTEM | Surgi-Vision, Inc. | Jun 22, 2011 | SESE |
| K100836 | CLEARPOINT SYSTEM | Surgivision, Inc. | Jun 16, 2010 | SESE |
Top Applicants
- Mri Interventions, Inc. — 2 clearances
- Surgivision, Inc. — 1 clearance
- Surgi-Vision, Inc. — 1 clearance
