Aperio AT2 DX System

FDA 510(k) K190332 · Leica Biosystems Imaging, Inc.

Substantially Equivalent

510(k) numberK190332

Submission

Device name
Aperio AT2 DX System
Applicant
Leica Biosystems Imaging, Inc.
Vista, CA, US
Received
February 14, 2019
Decision date
May 20, 2019
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
K253554Aperio GT 450 DX; Aperio GT 180 DXPSY · Traditional Leica Biosystems Imaging, Inc.08/07/2026SE
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

More from Philips Medical Systems Nederland B.V.

510(k)DeviceDecision
K253561Aperio iQC DX SoftwareSIX · Traditional 08/07/2026SE
K253554Aperio GT 450 DX; Aperio GT 180 DXPSY · Traditional 08/07/2026SE
K232202Aperio GT 450 DXPSY · Traditional 04/16/2024SE
K141109Aperio Epathology Eihc IVD SystemNOT · Traditional 07/29/2014SE

Questions and answers

When was Aperio AT2 DX System cleared by the FDA?

Aperio AT2 DX System (K190332) received a 510(k) decision of Substantially Equivalent on May 20, 2019, 95 days after the submission was received.

What is the product code of K190332?

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