đź“‹ FDA Reference

philips pagewriter touch cardiograph model m5000a series

Philips Medical Systems

Summary: The Philips PageWriter Touch Cardiograph is a diagnostic tool used to record and analyze the electrical activity of the heart. It is commonly used by cardiologists and other healthcare professionals in hospitals and clinics.

FDA Clearance Information

Pathway 510K
Decision Date April 25, 2002
Product Code DPS
Device Class Class 2
Evidence 419 studies

The Philips PageWriter Touch Cardiograph, manufactured by Philips Medical Systems, was cleared through the FDA 510(k) pathway on April 25, 2002. It is classified as a Class 2 device under product code DPS.

What It Is

The Philips PageWriter Touch Cardiograph is an advanced electrocardiograph machine designed to capture and interpret the electrical signals of the heart. It features a touchscreen interface for ease of use and provides high-quality ECG readings. This device is essential for diagnosing cardiac conditions such as arrhythmias, myocardial infarctions, and other heart-related abnormalities.

Clinical Applications

This cardiograph is primarily used in cardiology departments, emergency rooms, and general practice settings. It is vital for assessing patients with chest pain, palpitations, or other symptoms suggestive of cardiac issues. The device is also used in pre-operative evaluations and routine health check-ups, making it a versatile tool for both acute and chronic cardiac care.

Indications for Use

The FDA-cleared indications for this device include its use in recording and analyzing the heart's electrical activity. It is suitable for patients experiencing symptoms like chest pain or irregular heartbeats, aiding in the diagnosis of various cardiac conditions.

Practical Considerations

The Philips PageWriter Touch Cardiograph is compatible with standard ECG electrodes and paper. It offers various lead configurations, typically 12-lead, to provide comprehensive cardiac assessments. Clinicians should ensure proper electrode placement for accurate readings.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 PageWriter Touch Cardiograph used for?

It is used to record and analyze the electrical activity of the heart, helping diagnose conditions like arrhythmias and myocardial infarctions.

What specialties typically use this device?

Cardiologists, emergency medicine physicians, and general practitioners commonly use this device in hospitals and clinics.

What are the FDA-cleared indications?

The device is indicated for recording and analyzing the heart's electrical activity, suitable for diagnosing cardiac conditions in symptomatic patients.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.