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Digital Pathology Image Viewing And Management Software

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.

Global Registration Data
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Digital Pathology Image Viewing And Management Software
Pathology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QKQ

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Class 2

21 CFR 864.3700

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Pathology

Device Characteristics

No

No

No

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.