510(k) · Cleared
ClearedAperio iQC DX Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Biosystems Imaging, Inc. · SIX Digital Pathology Image Artifact Detection Software Device
Cleared on Aug 7, 2026 as substantially equivalent to K253554 (Leica Biosystems Imaging, Inc., 2026) after a 263-day review. Its family tree reaches back 4 generations to 2017.
- Decided
- Aug 7, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- SIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 3 generations backK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- 2 generations backK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- 1 generation backK253554 Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026
- This deviceK253561 Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −3 | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| −2 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| −1 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026 | — |
| 0 (this device) | K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026 | — |
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 SIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | K253554 | Aperio GT 450 DX; Aperio GT 180 DX Cleared while this submission was under review Summary page 5…oduct Code: PSY Classification Regulation: 21 CFR 864.3700 Classification Name: Whole Slide Imaging System Classification Panel: Pathology Premarket Notification Number: K253554 I. Intended Use/Indications for Use Aperio iQC DX Software is an artificial intelligence-based software intended to be use… | 2026 |
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 9 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All SIX devicesSIX Digital Pathology Image Artifact Detection Software Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIX
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIX
Too few SIX 510(k)s in any year since 2007 to give a median.
Recalls per year · SIX
No recall names SIX since 2007.
Adverse event reports per year · SIX
No MAUDE report names SIX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Aperio iQC DX Software is an artificial intelligence-based software intended to be used as an aid in the identification of artifacts in scanned whole slide images (WSIs) of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained, formalin-fixed paraffin embedded (FFPE) tissue that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Aperio iQC DX Software identifies the following…
Read the full statement (210 words)
Aperio iQC DX Software is an artificial intelligence-based software intended to be used as an aid in the identification of artifacts in scanned whole slide images (WSIs) of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained, formalin-fixed paraffin embedded (FFPE) tissue that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Aperio iQC DX Software identifies the following artifacts:
• Digital artifacts: out of focus, image striping, missing and clipped tissue
• Slide preparation artifact: air bubbles
• Other artifact: pen marks
Aperio iQC DX Software outputs the following:
• Binary ‘artifact detected’ or ‘no artifact detected’ for air bubbles, image striping, missing and clipped tissue, out of focus, and pen marks,
• Overlays highlighting the location of air bubbles and out of focus artifacts only, and
• Bounding boxes for missing and clipped tissue artifacts.
Aperio iQC DX Software is intended to be used in conjunction with the complete in-house laboratory image quality control workflow. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images when using the Aperio iQC DX Software. Aperio iQC DX Software is not intended to be used for diagnosis, prognosis, or prediction of disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253561: Aperio iQC DX Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253561
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026