FDA product code QKQ

Digital Pathology Image Viewing And Management Software

Pathology·Class 2·21 CFR 864.3700
US regulatory classifications
US Product Code (FDA)
QKQ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.3700
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Medical specialty
Pathology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

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About this record

Digital Pathology Image Viewing And Management Software is a medical device type in the Pathology 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.