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FDA 510(k)

Aperio iQC DX Software

K-Number: K253561 · 2026-08-07

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

Device Summary

Aperio iQC DX Software 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 K253561. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aperio iQC DX Software?

Aperio iQC DX Software 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 K253561.

When did Aperio iQC DX Software receive FDA 510(k) clearance?

Aperio iQC DX Software received FDA 510(k) clearance on 2026-08-07, under 510(k) number K253561.

Who is the listed applicant for Aperio iQC DX Software?

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 iQC DX Software?

The FDA product code for Aperio iQC DX Software is QKQ.

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.

K253554Aperio GT 450 DX; Aperio GT 180 DXK232202Aperio GT 450 DXK190332Aperio AT2 DX System

Related Devices (Code: QKQ)

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.

K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLCK243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter CorporationK250414CaloPixTribun Health

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.

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