Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → ORR — Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

# ORR · Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

_Neurology · 21 CFR 882.4560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR

## Overview

- **Product Code:** ORR
- **Device Name:** Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR/K181195.md) | ClearPoint System | Mri Interventions, Inc. | Nov 2, 2018 | SESE |
| [K171257](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR/K171257.md) | ClearPoint System | Mri Interventions, Inc. | Oct 20, 2017 | SESE |
| [K111073](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR/K111073.md) | SURGIVISION INC. CLEARPOINT SYSTEM | Surgi-Vision, Inc. | Jun 22, 2011 | SESE |
| [K100836](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR/K100836.md) | CLEARPOINT SYSTEM | Surgivision, Inc. | Jun 16, 2010 | SESE |

## Top Applicants

- Mri Interventions, Inc. — 2 clearances
- Surgivision, Inc. — 1 clearance
- Surgi-Vision, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ORR)

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