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FDA 510(k)

Aperio AT2 DX System

K-Number: K190332 · 2019-05-20

ApplicantLeica Biosystems Imaging, Inc.
Decision Date2019-05-20
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Aperio AT2 DX System 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 2019-05-20 under 510(k) number K190332. 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 AT2 DX System?

Aperio AT2 DX System is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Leica Biosystems Imaging, Inc.. The 510(k) number is K190332.

When did Aperio AT2 DX System receive FDA 510(k) clearance?

Aperio AT2 DX System received FDA 510(k) clearance on 2019-05-20, under 510(k) number K190332.

Who is the listed applicant for Aperio AT2 DX System?

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 AT2 DX System?

The FDA product code for Aperio AT2 DX System 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 SoftwareK253554Aperio GT 450 DX; Aperio GT 180 DXK232202Aperio GT 450 DX

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.

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.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 Limited

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.

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