đź“‹ FDA Reference

philips integris i 2000 system

Philips Medical Systems

Summary: The Philips Integris i 2000 System is a medical imaging device used primarily for angiographic procedures. It is utilized by interventional radiologists and cardiologists to visualize blood vessels and guide interventions.

FDA Clearance Information

Pathway 510K
Decision Date November 29, 1990
Product Code JAA
Device Class Class 2
Evidence 419 studies

The Philips Integris i 2000 System was cleared via the FDA 510(k) pathway on November 29, 1990. It is manufactured by Philips Medical Systems and is classified as a Class 2 device under product code JAA.

What It Is

The Philips Integris i 2000 System is an advanced angiography system designed for high-resolution imaging of blood vessels. It employs rotational and three-dimensional angiography techniques to provide detailed images, aiding in the diagnosis and treatment of vascular conditions. The system is equipped with software for 3D reconstruction, enhancing the visualization of complex vascular structures.

Clinical Applications

This device is commonly used in interventional radiology and cardiology settings for procedures such as embolization, angioplasty, and stent placement. It is particularly valuable in the assessment and treatment of cerebral aneurysms and other vascular abnormalities. The system is used in hospitals and specialized clinics, serving a patient population that includes those with cerebrovascular and cardiovascular diseases.

Indications for Use

The FDA indications suggest that the Philips Integris i 2000 System is intended for use in procedures involving the visualization and treatment of blood vessels. It is suitable for patients with conditions requiring detailed vascular imaging, such as aneurysms or arterial blockages.

Practical Considerations

The system typically requires compatibility with specific catheters and contrast media. Clinicians should be trained in the operation of the 3D reconstruction software to maximize the utility of the device. Proper patient positioning and contrast administration are crucial for optimal imaging results.

Related Literature

The linked study explored the use of the Philips Integris V5000 System for rotational and 3D angiography in patients with cerebral aneurysms. Conducted between 2000 and 2001, it involved 32 patients and detected 39 aneurysms. The study highlighted the system's ability to provide detailed images of aneurysms and their surrounding structures, aiding in clinical decision-making. However, the study was limited by its small sample size and single-center design.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 Integris i 2000 System used for?

It is used for angiographic imaging to visualize blood vessels and guide interventions in vascular procedures.

What specialties typically use this device?

Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinic settings.

What are the FDA-cleared indications?

The device is cleared for use in procedures requiring detailed imaging of blood vessels, such as those involving aneurysms or arterial blockages.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.