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U.S. Department of Health and Human Services

Product Classification

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Device digital pathology image viewing and management software
Regulation Description Whole slide imaging system.
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.
Physical State Software application and/or firmware, system components and accessories
Technical Method Digital Pathology Image Viewing and Management Software device is a software-only device that runs under a specified operating system for displaying and manipulating digital pathology images of scanned glass slides obtained from an FDA approved or cleared whole slide image (WSI) scanner. These images are viewed and manipulated by end users which are displayed and viewed on an FDA approved or cleared computer display. Image analysis software including Artificial Intelligence (AI) or Machine Learning (ML) based image analysis software are not within the scope of this product code.
Target Area Scanned digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) human-derived tissue
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodeQKQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.3700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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