Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aperio GT 450 DX; Aperio GT 180 DX

K-Number: K253554 · 2026-08-07

ApplicantLeica Biosystems Imaging, Inc.
Decision Date2026-08-07
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Aperio GT 450 DX; Aperio GT 180 DX is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Imaging, Inc.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K253554. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aperio GT 450 DX; Aperio GT 180 DX?

Aperio GT 450 DX; Aperio GT 180 DX is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Leica Biosystems Imaging, Inc.. The 510(k) number is K253554.

When did Aperio GT 450 DX; Aperio GT 180 DX receive FDA 510(k) clearance?

Aperio GT 450 DX; Aperio GT 180 DX received FDA 510(k) clearance on 2026-08-07, under 510(k) number K253554.

Who is the listed applicant for Aperio GT 450 DX; Aperio GT 180 DX?

The FDA 510(k) record lists Leica Biosystems Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aperio GT 450 DX; Aperio GT 180 DX?

The FDA product code for Aperio GT 450 DX; Aperio GT 180 DX is PSY.

Other records listing Leica Biosystems Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253561Aperio iQC DX SoftwareK232202Aperio GT 450 DXK190332Aperio AT2 DX System

Related Devices (Code: PSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.K251952VirasightVirasoft CorporationK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics LimitedK242783Roche Digital Pathology DxVentana Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑