GXT · Monitor, Lesion Temperature
Neurology · 21 CFR 882.5500 · Class 2
Overview
| Product Code | GXT |
|---|---|
| Device Name | Monitor, Lesion Temperature |
| Regulation | 21 CFR 882.5500 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
