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philips integris allura flat detector release 1 2
Philips Medical Systems North America
Summary: The Philips Integris Allura Flat Detector is a medical imaging device used primarily in interventional radiology and cardiology for procedures like embolization. It is utilized by radiologists and cardiologists to visualize blood vessels and guide interventions.
FDA Clearance Information
Pathway
510K
Number
K031333 ↗
Decision Date
May 13, 2003
Product Code
IZI
Device Class
Class 2
Evidence
419 studies
The Philips Integris Allura Flat Detector was cleared through the FDA 510(k) pathway on May 13, 2003. 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 Allura Flat Detector is an advanced imaging system designed for use in interventional procedures. It utilizes flat-panel detector technology to provide high-resolution, real-time X-ray images. This system enhances the clinician's ability to visualize complex vascular structures and guide therapeutic interventions with precision.
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 hospitals and specialized clinics where detailed vascular imaging is required. The system supports clinicians in treating conditions like aneurysms, arteriovenous malformations, and coronary artery disease.
Indications for Use
The FDA indications for this device include its use in procedures involving liquid embolization agents. It is suitable for patients requiring precise vascular intervention, such as those with vascular malformations or blockages.
Practical Considerations
The Philips Integris Allura Flat Detector is compatible with a variety of interventional tools and contrast agents. Clinicians should be familiar with the system's interface and imaging capabilities to optimize procedural outcomes. Regular maintenance and calibration are essential to ensure image quality and device performance.
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 Allura Flat Detector used for?
It is used for imaging and guiding interventional procedures in radiology and cardiology, such as embolization and angioplasty.
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 indicated for use in procedures involving liquid embolization agents, aiding in the treatment of vascular conditions.
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.