Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4565](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4565) → QLV — Field Generator Positioning Device

# QLV · Field Generator Positioning Device

_Neurology · 21 CFR 882.4565 · Class 1_

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

## Overview

- **Product Code:** QLV
- **Device Name:** Field Generator Positioning Device
- **Regulation:** [21 CFR 882.4565](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4565)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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