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philips digital cardiac imaging dci system
Philips Medical Systems North America
Summary: The Philips Digital Cardiac Imaging DCI System is a device used for digital coronary arteriography. It is primarily used for quantitative analysis of coronary artery dimensions. Key evidence highlights its accuracy in comparison to traditional cinefilm methods.
FDA Clearance Information
Pathway
510K
Number
K885327 ↗
Decision Date
May 11, 1989
Product Code
LMB
Device Class
Class 1
Evidence
419 studies
The Philips Digital Cardiac Imaging DCI System was cleared by the FDA via the 510(k) pathway on May 11, 1989. It is manufactured by Philips Medical Systems North America and classified as a Class 1 device under product code LMB.
What It Is
The Philips Digital Cardiac Imaging DCI System is a medical device designed for digital coronary arteriography. It facilitates the acquisition and analysis of coronary artery images, aiding in the assessment of coronary dimensions and the evaluation of interventional procedures.
Clinical Applications
This device is commonly used in clinical settings for the quantitative analysis of coronary artery dimensions, particularly in patients undergoing procedures such as percutaneous transluminal coronary angioplasty (PTCA). It is utilized to support decision-making in selecting appropriate recanalization devices.
Evidence Summary
The available literature includes five studies, primarily from the early 1990s, focusing on the accuracy and precision of digital coronary arteriography using the Philips DCI System. These studies include randomized controlled trials and comparative analyses.
Reported Outcomes
Published studies report that the Philips DCI System provides accurate and precise measurements of coronary artery dimensions. It has been validated against traditional cinefilm methods, demonstrating comparable or superior performance in both in vitro and in vivo settings.
Safety Profile
Reported complications include potential inaccuracies in measurements due to calibration errors. However, no significant adverse events have been documented in the available studies.
Evidence Limitations
The evidence is limited by the age of the studies, with most research conducted in the early 1990s. Further research is needed to evaluate the system's performance with modern imaging technologies and in 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 Digital Cardiac Imaging DCI System?
The device is indicated for digital coronary arteriography, particularly in assessing coronary artery dimensions during interventional procedures.
What outcomes have been reported in clinical studies?
Studies have reported accurate and precise measurements of coronary artery dimensions, with performance comparable to traditional cinefilm methods.
What complications have been reported?
Reported complications include potential measurement inaccuracies due to calibration errors, though no significant adverse events have been documented.
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.