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U.S. Department of Health and Human Services

Product Classification

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Device whole slide imaging system
Definition The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).
Physical State The whole slide imaging system consists of an image management system, a scanner and associated software, and a display monitor. The whole slide imaging system does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.
Technical Method The whole slide imaging system consists of an image management system, a scanner and associated software, and a display monitor. Pathologists view and interpret scanned digital images, employing appropriate processes to ensure the validity of the interpretation. The system may include web-based applications.
Target Area Surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue Not for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens.
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodePSY
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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