QXL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cabinet, Emission Computed Tomography System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1200
- Medical specialty
- Radiology
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| Aura 10 PET/CT (K231420) | Xeos Medical | 2023-08-10 |
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