đź“‹ FDA Reference
philips integris h hm system
Philips Medical Systems
Summary: The Philips Integris H HM System is a medical imaging device used primarily in interventional radiology for procedures like embolization. It is used by radiologists and interventional specialists to guide and perform minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K925302 ↗
Decision Date
December 17, 1992
Product Code
IZF
Device Class
Class 2
Evidence
419 studies
The Philips Integris H HM System was cleared through the FDA 510(k) pathway on December 17, 1992. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code IZF.
What It Is
The Philips Integris H HM System is an advanced imaging system designed for use in interventional radiology. It provides high-resolution imaging to assist clinicians in guiding catheters and other instruments during minimally invasive procedures. The system is equipped with digital imaging technology to enhance visualization of vascular structures and other anatomical features.
Clinical Applications
Commonly used in interventional radiology, the Philips Integris H HM System is essential for procedures such as embolization, where precise imaging is crucial. It is used in hospital settings, particularly in catheterization labs, and serves a diverse patient population requiring vascular interventions. Radiologists and interventional cardiologists frequently use this system to perform diagnostic and therapeutic procedures.
Indications for Use
The device is indicated for use in procedures involving liquid embolization agents, which are used to block blood vessels. This is particularly useful in treating conditions like arteriovenous malformations or tumors by reducing blood supply.
Practical Considerations
The Philips Integris H HM System is compatible with a range of catheter sizes and embolization materials. Clinicians should be familiar with the system's imaging capabilities and ensure proper calibration before procedures. Its digital interface allows for precise control and real-time imaging adjustments.
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 H HM System used for?
It is used for imaging and guiding interventional procedures, particularly embolization, in interventional radiology.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for procedures involving liquid embolization agents, used to block blood vessels in conditions like 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.