đź“Š Evidence-Based Reference
philips ict ct system
Philips Medical Systems Nederland
Summary: The Philips iCT CT System is a computed tomography device used for diagnostic imaging. It is primarily used in scenarios requiring detailed anatomical visualization. Key evidence highlights its efficacy in reducing radiation dose while maintaining image quality.
FDA Clearance Information
Pathway
510K
Number
K250648 ↗
Decision Date
June 27, 2025
Product Code
JAK
Device Class
Class 2
Evidence
419 studies
The Philips iCT CT System was cleared through the FDA 510(k) pathway on June 27, 2025. It is manufactured by Philips Medical Systems Nederland and is classified as a Class 2 device.
What It Is
The Philips iCT CT System is a computed tomography device designed to provide high-resolution images for diagnostic purposes. It utilizes advanced imaging technology to enhance image quality while minimizing radiation exposure.
Clinical Applications
The device is commonly used in clinical scenarios requiring detailed anatomical visualization, such as in the assessment of liver tumors, pulmonary artery variations, and coronary CT angiography. It is particularly useful in settings where dose reduction is a priority.
Evidence Summary
The available literature includes 12 studies, encompassing various study types such as RCTs and prospective studies, conducted between 2019 and 2024. These studies focus on image quality, diagnostic performance, and radiation dose optimization.
Reported Outcomes
Published studies report that the Philips iCT CT System effectively reduces radiation dose while maintaining diagnostic image quality. It has shown noninferiority in detecting malignant liver tumors compared to standard-dose CT. The device also supports detailed 3D reconstructions for preoperative planning.
Safety Profile
Reported complications include minimal adverse events related to radiation exposure, as the device is designed to optimize dose reduction. No significant safety concerns have been highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the short duration of follow-up in some studies. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
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 are the clinical indications for Philips iCT CT System?
The device is indicated for diagnostic imaging in scenarios such as liver tumor detection, pulmonary artery analysis, and coronary CT angiography.
What outcomes have been reported in clinical studies?
Studies report effective dose reduction and maintained image quality, with noninferiority in liver tumor detection compared to standard-dose CT.
What complications have been reported?
Reported complications include minimal adverse events related to radiation exposure, with no significant safety concerns highlighted.
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.