510(k) · Cleared

Cleared

Sectra Digital Pathology Module

K193054510(k) TraditionalCleared Mar 31, 2020151-day reviewClass II21 CFR 864.3700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sectra AB · QKQ Digital Pathology Image Viewing And Management Software

Cleared on Mar 31, 2020 as substantially equivalent to K190332 (Leica Biosystems Imaging, Inc., 2019) after a 151-day review. Its family tree reaches back 2 generations to 2017.

Decided: Mar 31, 2020
Review: 151 days
Class: Class II
Product code: QKQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN160056 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
1 generation backK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
This deviceK193054 Sectra Digital Pathology ModuleSectra AB · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN160056	Philips IntelliSite Pathology Solution	Philips Medical Systems Nederland B.V.	2017	—
−1	K190332	Aperio AT2 DX System	Leica Biosystems Imaging, Inc.	2019	—
0 (this device)	K193054	Sectra Digital Pathology Module	Sectra AB	2020	—

FIG. 1 — Lineage of K193054, 2017–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QKQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QKQ device

#1 K261380 Concentriq AP-Dxscore 12.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K190332	Aperio AT2 DX System Summary page 4 …mage Viewing and Management Software Predicate Device Identification: Proprietary/Trade Name: Aperio AT2 DX System 510(k) Number: K190332 Clearance Date: May 20, 2019 Classification Name: Whole Slide Imaging System Regu…	Leica Biosystems Imaging, Inc.	2019	—

Also cleared against K190332: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K190332.

How does its category compare?

All QKQ devices

QKQ Digital Pathology Image Viewing And Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · QKQ

7in 2025

2007high 7 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QKQ

226in 2025

2007high 226 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QKQ

No recall names QKQ since 2007.

Adverse event reports per year · QKQ

No MAUDE report names QKQ since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	0
2022	2	—	0
2023	0	—	0
2024	2	—	0
2025	7	226	0
2026	1	—	—

What is it indicated for?

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE…

Read the full statement (115 words)

For In Vitro Diagnostic Use

Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.

It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.

Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K193054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K193054: Sectra Digital Pathology Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193054

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026