Pure Global AI
FDA product code OLQ

Cross-Sectional Mammographic Xray System

UnknownClass 321 CFR
Verified
US regulatory classifications
US Product Code (FDA)
OLQ
View Product Code Classification
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes.

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01Mammography system02X-ray mammography03Breast imaging04Digital mammography05Tomosynthesis063D mammography07Breast cancer screening08Diagnostic mammography09X-ray device10Imaging system
About this record

Cross-Sectional Mammographic Xray System is a medical device type in the Unknown 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.