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philips obtracevue model sw rev g 00
Philips Medizin Systeme Boeblingen
Summary: The Philips OB TraceVue Model SW Rev G 00 is a medical device used for monitoring fetal and maternal parameters during labor and delivery. It is primarily used by obstetricians and healthcare professionals in maternity wards.
FDA Clearance Information
Pathway
510K
Number
K100420 ↗
Decision Date
July 26, 2010
Product Code
HGM
Device Class
Class 2
Evidence
419 studies
The Philips OB TraceVue Model SW Rev G 00 was cleared through the FDA 510(k) pathway on July 26, 2010. Manufactured by Philips Medizin Systeme Boeblingen, it is classified as a Class 2 device under product code HGM.
What It Is
The Philips OB TraceVue Model SW Rev G 00 is a comprehensive monitoring system designed to track fetal and maternal health parameters during labor and delivery. It integrates with hospital information systems to provide real-time data and alerts, aiding clinicians in making informed decisions. The device supports the monitoring of fetal heart rate, uterine contractions, and maternal vital signs, ensuring comprehensive care during childbirth.
Clinical Applications
This device is commonly used in obstetric settings, particularly in labor and delivery units. It assists in monitoring the well-being of both the mother and fetus, providing critical data that can influence clinical decisions during childbirth. Obstetricians, midwives, and maternity nurses frequently rely on this system to ensure safe and effective labor management. It is particularly useful in high-risk pregnancies where continuous monitoring is essential.
Indications for Use
The FDA indications suggest that this device is intended for monitoring fetal and maternal parameters during labor and delivery. It is suitable for use in hospital settings to ensure the safety and health of both mother and child during childbirth.
Practical Considerations
The Philips OB TraceVue system is typically compatible with existing hospital IT infrastructure, facilitating seamless integration. Clinicians should ensure proper calibration and setup to maintain accuracy. Familiarity with the system's interface and alert settings is crucial for effective use during labor and delivery.
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 Philips OB TraceVue Model SW Rev G 00 used for?
It is used for monitoring fetal and maternal health parameters during labor and delivery.
What specialties typically use this device?
Obstetricians, midwives, and maternity nurses in labor and delivery units typically use this device.
What are the FDA-cleared indications?
The device is indicated for monitoring fetal and maternal parameters during labor and delivery in hospital settings.
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.