DeviceClearance

Product code QXL— Radiology

Aura 10 PET/CT

Classification name
Cabinet, Emission Computed Tomography System
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code QXL under 21 CFR 892.1200, via openFDA

Market context for product code QXL

FDA has cleared 1 device under product code QXL, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXL

Recent clearances under product code QXL

Data sourced from openFDA. This site is unofficial and independent of the FDA.