510(k) · Cleared
ClearedAperio GT 450 DX; Aperio GT 180 DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Biosystems Imaging, Inc. · PSY Whole Slide Imaging System
Cleared on Aug 7, 2026 as substantially equivalent to K232202 (Leica Biosystems Imaging, Inc., 2024) after a 266-day review. Its family tree reaches back 3 generations to 2017. 1 later device descends from it.
- Decided
- Aug 7, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN160056 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- 1 generation backK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- This deviceK253554 Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253561 Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −2 | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| −1 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| 0 (this device) | K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026 | — |
| +1 | K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 PSY? 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 PSY device
- #1 K232202 Aperio GT 450 DXscore 34.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K232202 | Aperio GT 450 DXSummary page 5…Leica Biosystems Imaging, Inc. Predicate Device for Aperio GT 450 DX: Device Trade/Proprietary Name: Aperio GT 450 DX 510(k) Number: K232202 Traditional 510(k) Aperio GT Platform Page 1/18 Subject Device: Aper… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253561 | Aperio iQC DX Software | 2026 | 0 |
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 3 ancestors has a recall.
- Of its descendants, K253561 (Leica Biosystems Imaging, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K232202.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSY
265in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSY
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSY
1in 2023
MAUDE reports naming product code PSY, not matched to any one device; reports are not rates.
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 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 9 | 265 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 253 | 1 | — |
What is it indicated for?
Aperio GT 450 DX: The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 450 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual…
Read the full statement (260 words)
Aperio GT 450 DX:
The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 450 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio GT 450 DX.
Aperio GT 180 DX:
The Aperio GT 180 DX is an automated digital slide creation and viewing system. The Aperio GT 180 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 180 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
The Aperio GT 180 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio GT 180 DX.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253554: Aperio GT 450 DX; Aperio GT 180 DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253554
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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