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Pathology device clearances

Every FDA 510(k) decision for pathology devices in the last 12 months: the applicant, the device, where it is made and FDA's own record.

Decisions11
Applicants9
Latest2026-09-25

FDA decided 11 premarket notifications (510(k)s) for pathology devices from 9 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.

DecidedApplicantDeviceWhereRecord
2026-09-25SimBioSys, Inc.TumorSight Risk SHWChicago, IllinoisK260023
2026-08-07Leica Biosystems Imaging, Inc.Aperio GT 450 DX; Aperio GT 180 DX PSYVista, CaliforniaK253554
2026-08-07Leica Biosystems Imaging, Inc.Aperio iQC DX Software SIXVista, CaliforniaK253561
2026-08-05Proscia, Inc.Concentriq AP-Dx QKQPhiladelphia, PennsylvaniaK261380
2026-07-22Hamamatsu Photonics K.K.NanoZoomer S540MD Slide Scanner System PSYJPK260964
2026-07-17Virasoft CorporationVirasight PSYNew York City, New YorkK251952
2026-07-15Hamamatsu Photonics K.K.NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system PSYJPK253606
2026-05-12Datar Cancer Genetics Private LimitedCellDx-Tissue PZMINK260235
2026-05-04Artera, Inc.ArteraAI Breast SHWLos Altos, CaliforniaK254115
2025-12-09Infinitt Healthcare Co., Ltd.INFINITT DPS QKQKRK243449
2025-11-25Indica Labs, LLCHALO AP Dx QKQAlbuquerque, New MexicoK252762

Where this comes from

Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.

A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.

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Cite this page

Permanent URL: https://mentionfox.com/fda/510k/pathology
Last updated 2026-10-18
Pathology device clearances: 11 FDA 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/pathology