FDA 510(k)

Aperio AT2 DX System

K-Number: K190332 · 2019-05-20

Decision Date2019-05-20

Product CodePSY

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Aperio AT2 DX System is a medical device manufactured by Leica Biosystems Imaging, Inc.. It received FDA 510(k) clearance on 2019-05-20 under approval 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. It is manufactured by Leica Biosystems Imaging, Inc.. The 510(k) number is K190332.

When was Aperio AT2 DX System approved by the FDA?

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

What company makes Aperio AT2 DX System?

Aperio AT2 DX System is manufactured by Leica Biosystems Imaging, Inc..

What is the FDA product code for Aperio AT2 DX System?

The FDA product code for Aperio AT2 DX System is PSY.

Other Devices by Leica Biosystems Imaging, Inc.

K232202Aperio GT 450 DX

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Official Source

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