510(k) · Cleared
ClearedAperio AT2 DX System
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 May 20, 2019 as substantially equivalent to DEN160056 (Philips Medical Systems Nederland B.V., 2017) after a 95-day review. Its family tree reaches back 1 generation to 2017. 15 later devices descend from it.
- Decided
- May 20, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160056 (2017). 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- This deviceK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- Descendant · cites it directly · 10 of its ownK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK253554 Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK232879 Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK253561 Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261380 Concentriq AP-DxProscia, Inc. · 2026
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024 · cites it directly10descendants
- K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc. · 2026 · 2 generations on1descendant
- K232879Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc. · 2024 · cites it directly1descendant
- K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc. · 2026 · 3 generations on0descendants
- K261380Concentriq AP-DxProscia, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| +1 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| +2 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026 | — |
| +1 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | 2024 | 1 |
| +3 | K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026 | — |
| +2 | K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 5 | 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 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 |
|---|---|---|---|
| * | DEN160056 | Philips IntelliSite Pathology SolutionSummary page 4…ass II Product code: PSY IV. Predicate Device Philips IntelliSite Pathology Solution (PIPS) DEN160056 Page 1 V. Device Description Clearance of this premarket applica… | 2017 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System 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 AT2 DX System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Aperio AT2 DX System is…
Read the full statement (146 words)
The Aperio AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System 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 AT2 DX System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. 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 AT2 DX System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190332: Aperio AT2 DX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190332
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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