Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Pathology — Predicate Candidate Screening
342 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
36 daysmedian FDA review time
246 days90th percentile
342clearances 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 |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026-08-07 | 263 | 0 |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026-08-05 | 100 | 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 |
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | 2026-05-12 | 106 | 0 |
| K254115 | ArteraAI Breast | Artera, Inc. | 2026-05-04 | 136 | 0 |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | 2025-12-09 | 397 | 0 |
| K252762 | HALO AP Dx | Indica Labs, LLC | 2025-11-25 | 88 | 0 |
| K241868 | xR IVD | Tempus AI, Inc. | 2025-09-19 | 449 | 0 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025-08-29 | 239 | 0 |
| DEN240068 | ArteraAI Prostate | Artera, Inc. | 2025-07-31 | 248 | 0 |
| K243391 | AISight Dx | PathAI, Inc. | 2025-06-26 | 238 | 0 |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | 2025-06-20 | 81 | 0 |
| K242545 | RadiForce MX317W-PA | Eizo Corporation | 2025-05-23 | 269 | 0 |
| K250414 | CaloPix | Tribun Health | 2025-05-14 | 90 | 0 |
| K242244 | Viewer+ | Lumea, Inc. | 2025-03-14 | 226 | 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 |
| K241232 | Galen™ Second Read™ | Ibex Medical Analytics , Ltd. | 2025-01-24 | 267 | 0 |
| K241273 | FullFocus | Paige.Ai, Inc. | 2025-01-09 | 248 | 0 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. | 2024-12-28 | 458 | 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 |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 | 30 | 1 |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024-10-28 | 269 | 0 |
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | 2024-08-01 | 398 | 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 |
| K233126 | aetherSlide | Aetherai Co., Ltd. | 2024-05-30 | 246 | 0 |
| 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 |
| DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervica | Hologic, Inc. | 2024-01-31 | 887 | 0 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 | 88 | 0 |
| DEN210011 | Invitae Common Hereditary Cancers Panel | Invitae Corporation | 2023-09-29 | 914 | 0 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | 2022-12-23 | 718 | 0 |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2022-10-27 | 59 | 1 |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022-09-27 | 288 | 1 |
| K212361 | Novo | PathAI, Inc. | 2022-08-11 | 377 | 0 |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | 2022-03-01 | 349 | 0 |
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | 2021-12-10 | 151 | 0 |
| DEN200080 | Paige Prostate | Paige.Ai | 2021-09-21 | 264 | 0 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021-09-17 | 260 | 0 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Canc | Nyu Langone Medical Center | 2021-07-14 | 334 | 0 |
| K203364 | MDPC-8127 | Barco N.V. | 2021-04-15 | 150 | 0 |
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2020-08-05 | 216 | 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