Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PSY — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
237 daysmedian FDA review time
288 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026-08-07 | 266 | 0 |
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | 2026-07-22 | 121 | 0 |
| K251952 | Virasight | Virasoft Corporation | 2026-07-17 | 387 | 0 |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Sli | Hamamatsu Photonics K.K. | 2026-07-15 | 239 | 0 |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2025-03-06 | 79 | 0 |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | 2025-02-28 | 259 | 0 |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | 2024-12-17 | 92 | 1 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-12-10 | 81 | 0 |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2024-12-02 | 158 | 0 |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-06-24 | 270 | 0 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | 2024-06-14 | 270 | 1 |
| K232833 | HALO AP Dx | Indica Labs, Inc. | 2024-05-07 | 237 | 0 |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | 2024-04-16 | 265 | 0 |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024-04-16 | 266 | 0 |
| K230839 | Concentriq Dx | Proscia, Inc. | 2024-02-08 | 318 | 0 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 | 88 | 0 |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022-09-27 | 288 | 1 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021-09-17 | 260 | 0 |
| K203364 | MDPC-8127 | Barco N.V. | 2021-04-15 | 150 | 0 |
| K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019-09-20 | 30 | 0 |
| K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019-05-20 | 95 | 0 |
| K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017-10-04 | 77 | 0 |
| DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017-04-12 | 132 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda