QXL · Cabinet, Emission Computed Tomography System
Radiology · 21 CFR 892.1200 · Class 2
Overview
| Product Code | QXL |
|---|---|
| Device Name | Cabinet, Emission Computed Tomography System |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231420 | Aura 10 PET/CT | Xeos Medical | Aug 10, 2023 | SESE |
Top Applicants
- Xeos Medical — 1 clearance
