Product Classification

• Device: whole slide imaging system
• Regulation Description: 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 Code: PSY
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 9-124 ISO CIE 11664-1:2019
  Colorimetry - Part 1: CIE standard colorimetric observers
• 9-125 CIE ISO 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01
  Colorimetry - Part 2: CIE standard illuminants
• 9-126 CIE ISO 11664-3 First edition 2019-06
  Colorimetry - Part 3: CIE tristimulus values
• 9-127 CIE ISO 11664-4 First edition 2019-06
  Colorimetry - Part 4: CIE 1976 L*a*b* colour space
• 9-128 CIE ISO 11664-6 First edition 2014-02-01
  Colorimetry - Part 6: CIEDE2000 colour-difference formula
• 9-129 CIE ISO 61966-2-1 First edition 1999-10
  Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
• 9-139 ISO CIE 11664-5:2016
  Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
• 9-147 CIE ISO 11664-2 First edition 2022-08
  Colorimetry - Part 2: CIE standard illuminants
• 9-148 CIE ISO 11664-6 Second edition 2022-08
  Colorimetry - Part 6: CIEDE2000 colour-difference formula

Third Party Review

Not Third Party Eligible