Aperio GT 450 DX; Aperio GT 180 DX

FDA 510(k) K253554 · Leica Biosystems Imaging, Inc.

Substantially Equivalent

510(k) numberK253554

Submission

Device name
Aperio GT 450 DX; Aperio GT 180 DX
Applicant
Leica Biosystems Imaging, Inc.
Vista, CA, US
Received
November 14, 2025
Decision date
August 7, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PSY – Whole Slide Imaging System
Device class
Class II (moderate risk)
Regulation
21 CFR 864.3700
Specialty
Pathology

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield…

Other 510(k)s with product code PSY

510(k)DeviceApplicantDecision
K260964NanoZoomer S540MD Slide Scanner SystemPSY · Abbreviated Hamamatsu Photonics K.K.07/22/2026SE
K251952VirasightPSY · Traditional Virasoft Corporation07/17/2026SE
K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemPSY · Abbreviated Hamamatsu Photonics K.K.07/15/2026SE
K243871Philips IntelliSite Pathology Solution 5.1PSY · Traditional Philips Medical Systems Nederland B.V.03/06/2025SE
K241717E1000 Dx Digital Pathology SolutionPSY · Traditional Shandon Diagnostics Limited02/28/2025SE
K242783Roche Digital Pathology DxPSY · Special Ventana Medical Systems, Inc.12/17/2024SE
K242848Philips IntelliSite Pathology Solution 5.1PSY · Traditional Philips Medical Systems Nederland B.V.12/10/2024SE
K241871Philips IntelliSite Pathology SolutionPSY · Traditional Philips Medical Systems Nederland B.V.12/02/2024SE
K233204Philips IntelliSite Pathology Solution 5.1PSY · Traditional Philips Medical Systems Nederland B.V.06/24/2024SE
K232879Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional Ventana Medical Systems, Inc.06/14/2024SE

More from Ventana Medical Systems, Inc.

510(k)DeviceDecision
K253561Aperio iQC DX SoftwareSIX · Traditional 08/07/2026SE
K232202Aperio GT 450 DXPSY · Traditional 04/16/2024SE
K190332Aperio AT2 DX SystemPSY · Traditional 05/20/2019SE
K141109Aperio Epathology Eihc IVD SystemNOT · Traditional 07/29/2014SE

Questions and answers

When was Aperio GT 450 DX; Aperio GT 180 DX cleared by the FDA?

Aperio GT 450 DX; Aperio GT 180 DX (K253554) received a 510(k) decision of Substantially Equivalent on August 7, 2026, 266 days after the submission was received.

What is the product code of K253554?

The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.