De Novo · Granted
GrantedPhilips IntelliSite Pathology Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · PSY Whole Slide Imaging System
Granted on Apr 12, 2017 as a new device type through De Novo after a 132-day review. 39 later devices descend from it.
- Decided
- Apr 12, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
39 later devices descend from it, 9 citing it directly.
- This deviceDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- Descendant · cites it directly · 15 of its ownK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- Descendant · cites it directly · 14 of its ownK213883 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022 · Recalled
- Descendant · 2 generations on · 10 of its ownK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- Descendant · cites it directly · 8 of its ownK172174 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- Descendant · 2 generations on · 7 of its ownK233027 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K190332Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019 · cites it directly15descendants
- K213883NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022 · cites it directly14descendants
- K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024 · 2 generations on10descendants
- K172174Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017 · cites it directly8descendants
- K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| +1 | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| +1 | K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022 | 1 |
| +2 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| +1 | K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| +2 | K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (39)
See all 399 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190332 | Aperio AT2 DX System | 2019 | 15 |
| K213883 | NanoZoomer S360MD Slide scanner system | 2022 | 14 |
| K172174 | Philips IntelliSite Pathology Solution | 2017 | 8 |
| K241717 | E1000 Dx Digital Pathology Solution | 2025 | 0 |
| K233126 | aetherSlide | 2024 | 0 |
| K212361 | Novo | 2022 | 0 |
| K210811 | Dynamyx Digital Pathology Software | 2022 | 0 |
| K201005 | FullFocus | 2020 | 0 |
| K172922 | MMPC-4127F1 | 2017 | 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?
- Of its descendants, K190332 (Leica Biosystems Imaging, Inc., 2019) has gone furthest, with 15 descendants of its own.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS 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 PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS comprises the…
Read the full statement (130 words)
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS 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 PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS 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 PIPS.
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/DEN160056 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160056: Philips IntelliSite Pathology Solution.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160056
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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