đź“Š Evidence-Based Reference
Philips Inturis Cardio Image Viewing Package
Philips Medical Systems North America
Summary: The Philips Inturis Cardio Image Viewing Package is a medical imaging device designed for viewing cardiac images. It is primarily used in the context of embolization procedures. Key evidence includes studies on its application in structural heart imaging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K983821 ↗
Decision Date ?
December 11, 1998
Product Code ?
LLZ
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Inturis Cardio Image Viewing Package was cleared by the FDA via the 510(k) pathway on December 11, 1998. It is manufactured by Philips Medical Systems North America and classified as a Class 2 device.
What It Is
The Philips Inturis Cardio Image Viewing Package is a software package used for the visualization of cardiac images. It is intended for use in clinical settings to assist clinicians in the interpretation and analysis of cardiac imaging data.
FDA-Cleared Indications
- For viewing cardiac images to support clinical interpretation and analysis.
Clinical Applications
- Reviewing cardiac images in a clinical setting
- Supporting physician interpretation of cardiac imaging data
- Displaying cardiac images during evaluation and treatment planning
Evidence Summary
The available literature includes 10 studies, with a mix of randomized controlled trials, prospective and retrospective studies, and case series. These studies were published around the year 2025, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the Philips Inturis Cardio Image Viewing Package is effective in enhancing the visualization of cardiac structures, particularly in the context of structural heart interventions. It has been noted as a promising tool in complementing traditional imaging techniques.
Safety Profile
Reported complications include minimal adverse events related to the use of the device itself, as it primarily serves as a visualization tool. The safety profile is generally favorable, with no significant device-related complications noted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device's impact on clinical outcomes. Further research is needed to establish standardized protocols and to explore its efficacy in diverse clinical settings.
Practical Considerations
- This is a software image-viewing package rather than an implanted or catheter-based device, so it does not have physical device sizes.
- Compatibility depends on the imaging modalities, file formats, workstation, operating system, and connected hospital imaging systems supported by the specific software configuration.
- The FDA record provided does not establish MRI safety for the software itself. MRI safety depends primarily on the scanner, accessories, and any hardware used with the imaging system.
- Use should follow the manufacturer’s labeling, installation requirements, and institutional information-technology and medical-device policies.
- The provided FDA summary does not list contraindications; users should consult the current labeling for warnings, limitations, and supported clinical workflows.
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 Inturis Cardio Image Viewing Package?
The device is indicated for use in cardiac imaging, particularly in procedures involving embolization and structural heart interventions.
What outcomes have been reported in clinical studies?
Studies have reported enhanced visualization of cardiac structures, aiding in the accuracy of structural heart interventions.
What complications have been reported?
Safety data from evidence indicates minimal complications, with no significant device-related adverse events reported.
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.