FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
1–24 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Sep 25, 2026
TumorSight Risk
K260023 · SHW
SimBioSys, Inc.
Pathology · 263d
Cleared Aug 07, 2026
Aperio GT 450 DX
K253554 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 266d
Cleared Aug 07, 2026
Aperio iQC DX Software
K253561 · SIX
Leica Biosystems Imaging, Inc.
Pathology · 263d
Cleared Aug 05, 2026
Concentriq AP-Dx
K261380 · QKQ
Proscia, Inc.
Pathology · 100d
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