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FDA product code · Pathology · Class 2

QKQ: Digital Pathology Image Viewing And Management Software

QKQ is FDA's product code for "Digital Pathology Image Viewing And Management Software": a Class 2 device classified under 21 CFR 864.3700, reviewed by the Pathology panel.

510(k) review time for QKQ

Across 14 510(k) clearances under QKQ decided from 2018-01-01 to 2026-10-06, the median was 232 days from FDA receipt to decision. Half took between 93 and 264 days, and 80% were decided within 301 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QKQ, decisions 2018-01-01 to 2026-10-06 (n = 14)
Fastest81
25th percentile93
Median232
75th percentile264
80th percentile301
90th percentile369
Slowest397

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

FDA-recognized standards that cite QKQ

9 FDA recognized consensus standards cite QKQ, among them NEMA PS 3.1 - 3.20 2024e; NEMA PS 3.1 - 3.20 2025d; CIE ISO 11664-1:2019. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
  • 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
  • 9-124 CIE ISO 11664-1:2019 — Colorimetry - Part 1: CIE standard colorimetric observers
  • 9-126 ISO CIE 11664-3 First edition 2019-06 — Colorimetry - Part 3: CIE tristimulus values
  • 9-127 ISO CIE 11664-4 First edition 2019-06 — Colorimetry - Part 4: CIE 1976 L*a*b* colour space
  • 9-129 ISO CIE 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 CIE ISO 11664-5:2016 — Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u'v' uniform chromaticity scale diagram
  • 9-147 ISO CIE 11664-2 First edition 2022-08 — Colorimetry - Part 2: CIE standard illuminants
  • 9-148 ISO CIE 11664-6 Second edition 2022-08 — Colorimetry - Part 6: CIEDE2000 colour-difference formula

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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