510(k) · Cleared
ClearedAperio GT 450 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 Apr 16, 2024 as substantially equivalent to K190332 (Leica Biosystems Imaging, Inc., 2019) after a 266-day review. Its family tree reaches back 2 generations to 2017. 10 later devices descend from it.
- Decided
- Apr 16, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160056 (2017). 10 later devices descend from it, 9 citing it directly.
- 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 deviceK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK253554 Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253561 Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261380 Concentriq AP-DxProscia, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251952 VirasightVirasoft Corporation · 2026
- Descendant · cites it directly · 0 of its ownK252762 HALO AP DxIndica Labs, LLC · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026 · cites it directly1descendant
- K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026 · 2 generations on0descendants
- K261380Concentriq AP-DxProscia, Inc. · 2026 · cites it directly0descendants
- K251952VirasightVirasoft Corporation · 2026 · cites it directly0descendants
- K252762HALO AP DxIndica Labs, LLC · 2025 · cites it directly0descendants
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) | 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 | — |
| +2 | K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026 | — |
| +1 | K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026 | — |
| +1 | K251952 | Virasight | Virasoft Corporation | 2026 | — |
| +1 | K252762 | HALO AP Dx | Indica Labs, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 K233027 NanoZoomer S360MD Slide scanner systemscore 27.9 · 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 |
|---|---|---|---|
| * | K190332 | Aperio AT2 DX SystemSummary page 6…Page 1 of 16 Predicate Device Proprietary Name: Aperio AT2 DX System Submission Number: K190332 I. Intended Use The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is i… | 2019 |
What descends from it? (10)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | 2026 | 1 |
| K261380 | Concentriq AP-Dx | 2026 | 0 |
| K251952 | Virasight | 2026 | 0 |
| K252762 | HALO AP Dx | 2025 | 0 |
| K243391 | AISight Dx | 2025 | 0 |
| K250414 | CaloPix | 2025 | 0 |
| K241273 | FullFocus | 2025 | 0 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | 2024 | 0 |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | 2024 | 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 7 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253554 (Leica Biosystems Imaging, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K190332.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
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…
Read the full statement (185 words)
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.
Aperio GT 450 DX is comprised of the Aperio GT 450 DX scanner, which generates images in the Digital Imaging and
Communications in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file formats, the Aperio WebViewer
DX viewer, and the displays. The Aperio GT450 DX is intended to be used with the interoperable components specified
in Table 1.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232202: Aperio GT 450 DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232202
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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