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Cabinet, Emission Computed Tomography System

FDA product code QXL · 1 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1200
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-08-10 – 2023-08-10

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

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