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philips intellisite pathology solution
Philips Electronics Nederland
Summary: The Philips IntelliSite Pathology Solution is a digital pathology system used for high-resolution whole slide imaging. It is primarily used for diagnostic purposes in pathology labs. Key evidence highlights its role in enhancing diagnostic accuracy and collaboration.
FDA Clearance Information
Pathway
510K
Number
K192259 ↗
Decision Date
September 20, 2019
Product Code
PSY
Device Class
Class 2
Evidence
419 studies
The Philips IntelliSite Pathology Solution was cleared by the FDA through the 510(k) pathway on September 20, 2019. It is manufactured by Philips Electronics 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 that enables the scanning of glass slides to create high-resolution digital images. It is intended for use in diagnostic pathology to enhance accuracy and efficiency in slide review and analysis.
Clinical Applications
Common clinical scenarios for this device include its use in pathology labs for diagnostic purposes, such as in breast pathology and teleconsultation. It facilitates remote consultations and collaborative diagnostics by providing digital access to pathology slides.
Evidence Summary
The available literature includes 7 studies, with types ranging from retrospective to prospective analyses, conducted between 2022 and 2025. These studies explore the utility of digital pathology in various clinical settings.
Reported Outcomes
Published studies report that the Philips IntelliSite Pathology Solution enhances diagnostic accuracy and facilitates collaboration in pathology labs. It has been particularly beneficial in breast pathology and teleconsultation, allowing for efficient and accurate slide analysis.
Safety Profile
Reported complications include potential technical issues related to digital slide scanning and image quality. However, no significant adverse events have been documented in the provided studies.
Evidence Limitations
Evidence gaps include a need for more extensive studies on long-term outcomes and broader clinical applications. Some studies lack detailed safety data and comprehensive analysis of potential technical limitations.
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 efficiency, particularly in breast pathology and teleconsultation.
What outcomes have been reported in clinical studies?
Studies report improved diagnostic accuracy and collaboration in pathology labs, with significant benefits in breast pathology and teleconsultation.
What complications have been reported?
Reported complications include technical issues related to digital slide scanning, but no significant adverse events have been documented.
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.