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philips intellispace cardiovascular
Philips Medical Systems Nederland
Summary: Philips IntelliSpace Cardiovascular is a clinical software platform designed for cardiovascular imaging and analysis. It is primarily used for managing and interpreting cardiovascular data. Key evidence highlights its application in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K251215 ↗
Decision Date
October 2, 2025
Product Code
LLZ
Device Class
Class 2
Evidence
419 studies
The Philips IntelliSpace Cardiovascular was cleared through the FDA 510(k) pathway on October 2, 2025. It is manufactured by Philips Medical Systems Nederland and is classified as a Class 2 device under product code LLZ.
What It Is
Philips IntelliSpace Cardiovascular is a software platform that facilitates the management and analysis of cardiovascular imaging data. It is intended for use by clinicians in the interpretation and reporting of cardiovascular images, enhancing diagnostic accuracy and workflow efficiency.
Clinical Applications
Commonly used in hospitals and clinics, this device supports the assessment of cardiovascular conditions through advanced imaging techniques. It is particularly useful in scenarios requiring detailed analysis of cardiac and vascular structures.
Evidence Summary
The available literature includes 9 studies, encompassing various study types such as RCTs, prospective, and retrospective studies, published between 2021 and 2024. These studies provide insights into the device's clinical utility and effectiveness.
Reported Outcomes
Published studies report that the Philips IntelliSpace Cardiovascular platform enhances diagnostic capabilities in cardiovascular imaging. It has been shown to improve the accuracy of cardiac assessments and streamline clinical workflows, contributing to better patient management.
Safety Profile
Reported complications include potential software-related errors that could impact image interpretation. However, no significant adverse events directly associated with the device's use have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and the device's impact on clinical decision-making.
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 IntelliSpace Cardiovascular?
The device is indicated for use in the management and analysis of cardiovascular imaging data, aiding in the diagnosis and treatment planning of cardiovascular diseases.
What outcomes have been reported in clinical studies?
Studies have reported improved diagnostic accuracy and workflow efficiency in cardiovascular imaging, enhancing patient management.
What complications have been reported?
Safety data from evidence indicate potential software-related errors, but no significant adverse events have been directly linked to the device's use.
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.