đź“‹ FDA Reference
philips dsi system release 3 2
Philips Medical Systems
Summary: The Philips DSI System Release 3 2 is a medical device used in embolization procedures, primarily by interventional radiologists and cardiologists. It is designed to deliver liquid embolic agents to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K920793 ↗
Decision Date
July 17, 1992
Product Code
IZJ
Device Class
Class 2
Evidence
419 studies
The Philips DSI System Release 3 2 was cleared by the FDA via the 510(k) pathway on July 17, 1992. It is manufactured by Philips Medical Systems and classified as a Class 2 device under product code IZJ.
What It Is
The Philips DSI System Release 3 2 is a medical device used for delivering liquid embolic agents during embolization procedures. It operates by allowing precise control and delivery of embolic materials to target vascular sites, aiding in the treatment of conditions such as arteriovenous malformations or aneurysms. The system is designed to enhance the safety and efficacy of embolization procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is employed in procedures to treat vascular abnormalities, such as arteriovenous malformations, aneurysms, or to control bleeding. The device is particularly useful in hospital settings where minimally invasive techniques are preferred for managing complex vascular conditions.
Indications for Use
The Philips DSI System is indicated for use in embolization procedures, which involve the intentional blockage of blood vessels. It is suitable for patients with conditions that require the occlusion of abnormal blood vessels to prevent bleeding or to reduce blood flow to a specific area.
Practical Considerations
When using the Philips DSI System, clinicians should consider the compatibility of the liquid embolic agents with the device. Proper technique is crucial to ensure precise delivery and avoid complications. The system is typically compatible with a range of catheter sizes, allowing for flexibility in various clinical scenarios.
Related Literature
The linked study from the PROMETHEUS registry examined thrombotic risk in patients with acute coronary syndromes discharged on prasugrel or clopidogrel. It highlighted the importance of tailoring antithrombotic strategies based on individual thrombotic risk, as per the 2020 ESC guidelines. The study found that the benefits of prasugrel versus clopidogrel may vary with thrombotic risk, although further research is needed to fully understand the prognostic impact of high thrombotic risk criteria.
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 is the Philips DSI System Release 3 2 used for?
It is used for delivering liquid embolic agents during embolization procedures to treat vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is cleared for use in embolization procedures to occlude abnormal blood vessels, such as in arteriovenous malformations or aneurysms.
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.