QXL
- Product code
- QXL
- Device name
- Cabinet, Emission Computed Tomography System
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1200
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures
Official FDA classification page: QXL
Classification and pathway per current FDA publications. Data from openFDA (CC0).