FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,105 results
1–24 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Jul 22, 2026
NanoZoomer S540MD Slide Scanner System
K260964 · PSY
Hamamatsu Photonics K.K.
Pathology · 121d
Cleared Jul 17, 2026
Virasight
K251952 · PSY
Virasoft Corporation
Pathology · 387d
Cleared Jul 15, 2026
NanoZoomer S20MD Slide scanner system
K253606 · PSY
Hamamatsu Photonics K.K.
Pathology · 239d
Cleared Jul 02, 2026
OptraSCAN System
K260755 · NOT
Optrascan, Inc.
Pathology · 115d
Cleared May 12, 2026
CellDx-Tissue
K260235 · PZM
Datar Cancer Genetics Private Limited
Pathology · 106d
Cleared May 04, 2026
ArteraAI Breast
K254115 · SHW
Artera, Inc.
Pathology · 136d
Cleared Dec 09, 2025
INFINITT DPS
K243449 · QKQ
Infinitt Healthcare Co., Ltd.
Pathology · 397d
Cleared Nov 25, 2025
HALO AP Dx
K252762 · QKQ
Indica Labs, LLC
Pathology · 88d
Cleared Sep 19, 2025
xR IVD
K241868 · PZM
Tempus AI, Inc.
Pathology · 449d
Cleared Aug 29, 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
K250003 · PZM
Geneseeq Technology, Inc.
Pathology · 239d
Not Cleared Jul 31, 2025
ArteraAI Prostate
DEN240068 · SFH
Artera, Inc.
Pathology · 248d
Cleared Jun 26, 2025
AISight Dx
K243391 · QKQ
PathAI, Inc.
Pathology · 238d
Cleared Jun 20, 2025
PathPresenter Clinical Viewer
K250968 · QKQ
Pathpresenter Corporation
Pathology · 81d
Cleared May 23, 2025
RadiForce MX317W-PA
K242545 · PZZ
Eizo Corporation
Pathology · 269d
Cleared May 14, 2025
CaloPix
K250414 · QKQ
Tribun Health
Pathology · 90d
Cleared Mar 14, 2025
Viewer+
K242244 · QKQ
Lumea, Inc.
Pathology · 226d
Cleared Mar 06, 2025
Philips IntelliSite Pathology Solution 5.1
K243871 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 79d
Cleared Feb 28, 2025
E1000 Dx Digital Pathology Solution
K241717 · PSY
Shandon Diagnostics Limited
Pathology · 259d
Cleared Jan 24, 2025
Galen™ Second Read™
K241232 · QPN
Ibex Medical Analytics , Ltd.
Pathology · 267d
Cleared Jan 09, 2025
FullFocus
K241273 · QKQ
Paige.Ai, Inc.
Pathology · 248d
Cleared Dec 28, 2024
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
K233119 · PZZ
Shenzhen Beacon Display Technology...
Pathology · 458d
Cleared Dec 17, 2024
Roche Digital Pathology Dx
K242783 · PSY
Ventana Medical Systems, Inc.
Pathology · 92d
Cleared Dec 10, 2024
Philips IntelliSite Pathology Solution 5.1
K242848 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 81d
Not Cleared Dec 05, 2024
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
DEN240025 · SDP
Ventana Medical Systems, Inc.
Pathology · 190d