đź“‹ FDA Reference
Philips Integris 3d Ra Option
Philips Medical Systems North America
Summary: The Philips Integris 3D RA Option is a medical imaging device used primarily in interventional radiology for 3D rotational angiography. It is utilized by radiologists and interventional specialists to enhance visualization during procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K983877 ↗
Decision Date ?
December 21, 1998
Product Code ?
IZI
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Integris 3D RA Option was cleared through the FDA 510(k) pathway on December 21, 1998. Manufactured by Philips Medical Systems North America, it is a Class 2 device under product code IZI.
What It Is
The Philips Integris 3D RA Option is an advanced imaging system designed to provide three-dimensional rotational angiography. It enhances the visualization of vascular structures by rotating around the patient to capture detailed images. This technology aids in precise diagnosis and treatment planning by offering a comprehensive view of the vasculature.
FDA-Cleared Indications
- Use with compatible angiography systems to acquire three-dimensional rotational angiographic images.
- Use for vascular imaging during procedures involving liquid embolization agents, as described in the FDA-cleared labeling.
Clinical Applications
- Three-dimensional visualization of blood vessels during interventional procedures.
- Imaging to support planning and guidance of procedures that use liquid embolization agents.
- Rotational angiographic imaging in an angiography suite with a compatible Philips Integris system.
Practical Considerations
- This is an imaging option or system component rather than an implantable device; it requires a compatible Philips Integris angiography platform.
- The system uses X-rays and a rotating C-arm or imaging assembly, so room clearance, patient positioning, and collision checks are important.
- It is not an MRI device and should not be brought into the MRI scanner room unless the specific system components are confirmed to be MRI safe or conditionally safe.
- Use requires trained radiology or interventional staff familiar with rotational angiography, three-dimensional image reconstruction, radiation safety, and the system’s operating instructions.
- Patient size, positioning, motion, metal objects, and contrast timing can affect image quality and may limit the usefulness of three-dimensional reconstructions.
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 3D RA Option used for?
It is used for 3D rotational angiography to enhance vascular imaging during interventional procedures.
What specialties typically use this device?
Interventional radiology and cardiology specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving liquid embolization agents, providing detailed vascular imaging.
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.