QLV · Field Generator Positioning Device
Neurology · 21 CFR 882.4565 · Class 1
Overview
| Product Code | QLV |
|---|---|
| Device Name | Field Generator Positioning Device |
| Regulation | 21 CFR 882.4565 |
| Device Class | Class 1 |
| Review Panel | Neurology |
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.
Cleared Devices (0)
No cleared devices on record.
