Product Classification

• 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 Code: QKQ
• 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: Ineligible
• 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
• 12-352 NEMA PS 3.1 - 3.20 2023e
  Digital Imaging and Communications in Medicine (DICOM) Set
• 12-363 NEMA PS 3.1 - 3.20 2024e
  Digital Imaging and Communications in Medicine (DICOM) Set

Third Party Review

Not Third Party Eligible