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) → QRI — Surgical Planning Software For Neurological Stereotaxic Instruments

# QRI · Surgical Planning Software For Neurological Stereotaxic Instruments

_Neurology · 21 CFR 882.4560 · Class 2_

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

## Overview

- **Product Code:** QRI
- **Device Name:** Surgical Planning Software For Neurological Stereotaxic Instruments
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231141](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/QRI/K231141.md) | STarFix Designer Software C0265 | FHC, Inc. | Sep 8, 2023 | SESE |

## Top Applicants

- FHC, Inc. — 1 clearance

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

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