# DEN160056: Philips IntelliSite Pathology Solution

- Pathway: De Novo (Direct)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Apr 12, 2017 after 132 days
- Product code: PSY (Whole Slide Imaging System)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 9 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K190332: Aperio AT2 DX System (2019), 15 descendants of its own
- K213883: NanoZoomer S360MD Slide scanner system (2022), 14 descendants of its own
- K232202: Aperio GT 450 DX (2024), 10 descendants of its own
- K172174: Philips IntelliSite Pathology Solution (2017), 8 descendants of its own
- K233027: NanoZoomer S360MD Slide scanner system (2023), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN160056
Methodology: https://510kreport.com/methodology