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philips intellisite pathology solution
Philips Medical Systems Nederland
Summary: The Philips IntelliSite Pathology Solution is a digital pathology device used for high-resolution whole slide imaging. It is primarily used for enhancing diagnostic accuracy and collaboration in pathology. Key evidence highlights its integration in clinical settings and its impact on diagnostic workflows.
FDA Clearance Information
Pathway 510K
Number K241871 ↗
Decision Date December 2, 2024
Product Code PSY
Device Class Class 2
Evidence 419 studies
The Philips IntelliSite Pathology Solution was cleared by the FDA via the 510(k) pathway on December 2, 2024. It is manufactured by Philips Medical Systems Nederland and classified as a Class 2 device under product code PSY.
What It Is
The Philips IntelliSite Pathology Solution is a digital pathology system designed for creating high-resolution digital images of pathology slides. It is intended for use in primary diagnostic settings, enabling pathologists to review and annotate digital slides for enhanced diagnostic accuracy.
Clinical Applications
Common clinical scenarios for the Philips IntelliSite Pathology Solution include its use in surgical pathology for diagnostic purposes, teleconsultation, and educational applications. It is particularly useful in settings requiring collaboration and remote access to pathology expertise.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as RCTs and case series, conducted between 2022 and 2025. These studies explore the device's application in different pathology contexts, including liver and breast pathology.
Reported Outcomes
Published studies report that the Philips IntelliSite Pathology Solution enhances diagnostic accuracy and facilitates collaboration among pathologists. It has been shown to improve workflow efficiency in pathology departments and supports the integration of digital pathology in clinical practice.
Safety Profile
Reported complications include challenges in adapting to digital workflows and potential technical issues with image resolution. However, no significant adverse events related to patient safety have been documented in the available studies.
Evidence Limitations
Current evidence is limited by the heterogeneity of study designs and the relatively small sample sizes in some studies. Further research is needed to explore long-term outcomes and the impact of digital pathology on patient care across diverse clinical settings.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source → PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source → PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source → PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source → PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source → PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source → PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source → PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source → PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Philips IntelliSite Pathology Solution?
The device is indicated for use in digital pathology to enhance diagnostic accuracy and facilitate collaboration in clinical settings.
What outcomes have been reported in clinical studies?
Studies have reported improved diagnostic accuracy, enhanced workflow efficiency, and successful integration into clinical practice.
What complications have been reported?
Reported complications include adaptation challenges to digital workflows and potential technical issues, but no significant adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.