510(k) · Cleared
ClearedPhilips 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
Cleared on Sep 17, 2021 as substantially equivalent to K192259 (Philips Electronics Nederland B.V., 2019) after a 260-day review. Its family tree reaches back 3 generations to 2017. 4 later devices descend from it.
- Decided
- Sep 17, 2021
- Review
- 260 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN160056 (2017). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK172174 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 1 generation backK192259 Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. · 2019
- This deviceK203845 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2021
- Descendant · cites it directly · 2 of its ownK233204 Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2024
- Descendant · 2 generations on · 1 of its ownK242848 Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2024
- Descendant · 3 generations on · 0 of its ownK243871 Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2025
- Descendant · cites it directly · 0 of its ownK240303 MetaLite DX Digital Pathology SoftwareJellox Biotech, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K233204Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2024 · cites it directly2descendants
- K242848Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2024 · 2 generations on1descendant
- K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. · 2025 · 3 generations on0descendants
- K240303MetaLite DX Digital Pathology SoftwareJellox Biotech, Inc. · 2024 · 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 | K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −1 | K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019 | — |
| 0 (this device) | K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021 | — |
| +1 | K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024 | — |
| +2 | K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024 | — |
| +3 | K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2025 | — |
| +1 | K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K192259 | Philips IntelliSite Pathology SolutionSummary page 4…lassification Name: Whole Slide Imaging System Classification Panel: Pathology Predicate device Device Trade Name: Philips IntelliSite Pathology Solution 510(k) Number: K192259 (September 20, 2019) Device description Philips IntelliSite Pathology Solution (PIPS) is an automated digital sli… | 2019 |
What descends from it? (4)
2 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233204 (Philips Medical Systems Nederland B.V., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K192259.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 as stated in the FDA summary.
https://510kreport.com/device/K203845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203845: Philips IntelliSite Pathology Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203845
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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