Product Classification

• Device: digital pathology display
• Regulation Description: Whole slide imaging system.
• Definition: The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists.
• Physical State: Hardware and embedded software
• Technical Method: Hardware and embedded software for displaying digital pathology images of tissue on glass slides.
• Target Area: Histopathology slides of human clinical tissue specimens
• Regulation Medical Specialty: Pathology
• Review Panel: Pathology
• Product Code: PZZ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc