FDA Product Code QXL: Cabinet, Emission Computed Tomography System
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
Leading manufacturers include Xeos Medical.
FDA 510(k) Cleared Cabinet, Emission Computed Tomography System Devices (Product Code QXL)
About Product Code QXL - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QXL since 2023, with 1 receiving FDA clearance (average review time: 86 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QXL devices are reviewed by the Radiology panel. Browse all Radiology devices →