QXL — Cabinet, Emission Computed Tomography System Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K231420xeos medicalAura 10 PET/CTAugust 10, 2023