FDA product code · Pathology · Class 2
PSY: Whole Slide Imaging System
PSY is FDA's product code for "Whole Slide Imaging System": a Class 2 device classified under 21 CFR 864.3700, reviewed by the Pathology panel.
510(k) review time for PSY
Across 21 510(k) clearances under PSY decided from 2018-01-01 to 2026-10-06, the median was 239 days from FDA receipt to decision. Half took between 95 and 266 days, and 80% were decided within 270 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 95 |
| Median | 239 |
| 75th percentile | 266 |
| 80th percentile | 270 |
| 90th percentile | 288 |
| Slowest | 387 |
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 PSY
7 FDA recognized consensus standards cite PSY, among them CIE ISO 11664-1:2019; ISO CIE 11664-3 First edition 2019-06; ISO CIE 11664-4 First edition 2019-06. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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.