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philips intellisite pathology solution 5 1
Philips Medical Systems Nederland
Summary: The Philips IntelliSite Pathology Solution 5 1 is a digital pathology system used for histopathology diagnosis. It is FDA 510k cleared and supported by studies showing comparable diagnostic accuracy to traditional methods.
FDA Clearance Information
Pathway
510K
Number
K233204 ↗
Decision Date
June 24, 2024
Product Code
PSY
Device Class
Class 2
Evidence
419 studies
The Philips IntelliSite Pathology Solution 5 1 was cleared via the FDA 510k pathway on June 24, 2024. It is manufactured by Philips Medical Systems Nederland and classified as a Class 2 device.
What It Is
The Philips IntelliSite Pathology Solution 5 1 is a digital pathology system designed for the clinical application of histopathology diagnosis. It enables the digital assessment of pathology slides, facilitating remote and efficient diagnostic workflows.
Clinical Applications
This device is commonly used in clinical scenarios requiring histopathology diagnosis, such as in hospital networks and laboratories adopting digital pathology for routine diagnostic purposes. It supports the transition from traditional microscopy to digital imaging.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2017 to 2025. These studies encompass various types, including retrospective and prospective analyses, focusing on the diagnostic efficiency and implementation of digital pathology.
Reported Outcomes
Published studies report that digital pathology using the Philips IntelliSite Pathology Solution 5 1 provides diagnostic accuracy comparable to traditional optical methods. The studies highlight its potential for efficient integration into routine histopathology workflows.
Safety Profile
Reported complications include concerns about interpretative time efficiency compared to traditional methods. However, no significant adverse events related to device use were identified in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on diagnostic efficiency rather than long-term clinical outcomes. Further research is needed to explore broader clinical applications and potential barriers to adoption.
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 5 1?
The device is indicated for digital pathology applications, particularly in histopathology diagnosis within hospital networks and laboratories.
What outcomes have been reported in clinical studies?
Studies report comparable diagnostic accuracy to traditional methods, with potential for efficient integration into routine workflows.
What complications have been reported?
Reported complications include concerns about interpretative time efficiency, but no significant adverse events were identified.
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.