FDA product code QXL

Cabinet, Emission Computed Tomography System

Radiology·Class 2·21 CFR 892.1200
US regulatory classifications
US Product Code (FDA)
QXL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.1200
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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

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About this record

Cabinet, Emission Computed Tomography System is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.