FDA 510(k)

Sectra Digital Pathology Module

K-Number: K193054 · 2020-03-31

Decision Date2020-03-31

Product CodeQKQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Sectra Digital Pathology Module is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K193054. 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 Sectra Digital Pathology Module?

Sectra Digital Pathology Module is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Sectra AB. The 510(k) number is K193054.

When did Sectra Digital Pathology Module receive FDA 510(k) clearance?

Sectra Digital Pathology Module received FDA 510(k) clearance on 2020-03-31, under 510(k) number K193054.

Who is the listed applicant for Sectra Digital Pathology Module?

The FDA 510(k) record lists Sectra AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sectra Digital Pathology Module?

The FDA product code for Sectra Digital Pathology Module is QKQ.

Other records listing Sectra AB 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.

K232208Sectra Digital Pathology Module (Version 3.3)

Related Devices (Code: QKQ)

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLC K243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation

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.