Product code QXL

Device name

Cabinet, Emission Computed Tomography System

Medical specialty

Radiology

Device class

2

Regulation number

892.1200

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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

Source

FDA openFDA device classification dataset