QXL — Cabinet, Emission Computed Tomography System Class II
FDA product code QXL covers "Cabinet, Emission Computed Tomography System", a Class II medical device regulated under 21 CFR 892.1200. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXL
- Device Class
- Class II
- Regulation Number
- 892.1200
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231420 | xeos medical | Aura 10 PET/CT | August 10, 2023 |