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philips tracemaster ecg management system models m5100a and m5101a
Philips Medical Systems
Summary: The Philips TraceMaster ECG Management System is a digital platform used for managing and analyzing electrocardiograms (ECGs). It is primarily used by cardiologists and healthcare providers in hospitals and clinics to streamline ECG workflows and improve patient care.
FDA Clearance Information
Pathway
510K
Number
K032103 ↗
Decision Date
July 22, 2003
Product Code
DSH
Device Class
Class 2
Evidence
419 studies
The Philips TraceMaster ECG Management System, manufactured by Philips Medical Systems, received FDA clearance via the 510(k) pathway on July 22, 2003. It is classified as a Class 2 medical device under product code DSH.
What It Is
The Philips TraceMaster ECG Management System is a comprehensive digital solution designed to manage, store, and analyze ECG data. It integrates with various ECG machines to facilitate the collection and interpretation of cardiac data. This system enhances the efficiency of cardiac care by providing clinicians with easy access to patient ECG records and advanced analytical tools.
Clinical Applications
This device is commonly used in cardiology departments within hospitals and outpatient clinics. It supports clinicians in diagnosing and monitoring heart conditions such as arrhythmias, myocardial infarctions, and other cardiac abnormalities. By centralizing ECG data, it aids in longitudinal patient monitoring and facilitates collaboration among healthcare providers.
Indications for Use
The Philips TraceMaster ECG Management System is indicated for use in managing and analyzing ECG data. It is suitable for patients undergoing cardiac evaluation, helping clinicians to diagnose and monitor heart-related conditions effectively.
Practical Considerations
The system is compatible with multiple ECG machine models, allowing seamless integration into existing hospital infrastructure. It typically supports a range of ECG formats and can be customized to fit specific clinical workflows, enhancing its utility in diverse healthcare settings.
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 TraceMaster ECG Management System used for?
It is used for managing, storing, and analyzing ECG data to aid in the diagnosis and monitoring of cardiac conditions.
What specialties typically use this device?
Cardiologists and other healthcare providers in cardiology departments and clinics typically use this system.
What are the FDA-cleared indications?
The system is cleared for managing and analyzing ECG data to assist in cardiac evaluations.
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.