📋 FDA Reference
Philips Integris C2000 System
Philips Medical Systems North America
Summary: The Philips Integris C2000 System is a medical imaging device used primarily for interventional radiology procedures. It is utilized by radiologists and interventional cardiologists to guide and perform minimally invasive procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K902542 ↗
Decision Date ?
August 17, 1990
Product Code ?
IZI
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Integris C2000 System was cleared through the FDA 510(k) pathway on August 17, 1990. Manufactured by Philips Medical Systems North America, it is classified as a Class 2 device under product code IZI.
What It Is
The Philips Integris C2000 System is a sophisticated imaging device designed for use in interventional radiology. It combines fluoroscopy and digital imaging to provide real-time visualization of the vascular system. This system aids clinicians in guiding catheters and other instruments during minimally invasive procedures, enhancing precision and patient safety.
FDA-Cleared Indications
- Intended for diagnostic imaging and visualization during procedures requiring fluoroscopy and digital angiography.
- Intended to assist in the guidance and positioning of catheters and other interventional instruments under X-ray imaging.
- The available record identifies the system under FDA product code IZI, associated with imaging systems used with liquid embolic agents; the specific cleared labeling should be reviewed before attributing a particular embolic agent or procedure.
Clinical Applications
- Fluoroscopic guidance for catheter-based vascular procedures
- Digital angiography for imaging arteries and veins
- Imaging support during embolization procedures when used with compatible devices and agents
- Imaging guidance during selected cardiac or peripheral vascular interventions
Practical Considerations
- This is an X-ray fluoroscopy system, not an MRI system; it is not considered MRI safe and should not be brought into the MRI scanner room unless specifically evaluated and approved for that environment.
- Use only compatible catheters, guidewires, contrast media, and embolization products according to the system documentation and the separate product labeling.
- Fluoroscopy and digital angiography expose patients and staff to ionizing radiation; dose optimization, shielding, collimation, and dose monitoring are important.
- The system requires scheduled preventive maintenance, calibration, quality-control testing, and trained operators.
- The record does not establish a universal patient size or table-weight limit; users should verify the specific system configuration, table rating, field of view, and accessory compatibility in the applicable operator manual.
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 Integris C2000 System used for?
It is used for real-time imaging during interventional radiology procedures, such as angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is cleared for use in procedures involving liquid embolization agents, targeting conditions like aneurysms and arteriovenous malformations.
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.