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Philips Heartstart 12 Lead Transfer Station Model 989803142521
Philips Medical Systems
Summary: The Philips HeartStart 12 Lead Transfer Station is a medical device used to transfer 12-lead ECG data. It is primarily used by healthcare professionals in cardiology and emergency medicine settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071391 ↗
Decision Date ?
September 7, 2007
Product Code ?
MSX
Device Class ?
Class 2
Evidence ?
419 studies
The Philips HeartStart 12 Lead Transfer Station was cleared through the FDA 510(k) pathway on September 7, 2007. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The Philips HeartStart 12 Lead Transfer Station is a device designed to facilitate the transfer of 12-lead ECG data from the point of care to a central system for further analysis and storage. It helps streamline the workflow in clinical settings by ensuring that critical cardiac data is efficiently transmitted for review by healthcare providers. This device is particularly useful in emergency and cardiology departments where rapid access to ECG data is crucial for patient management.
FDA-Cleared Indications
- Transfer 12-lead ECG data from compatible ECG acquisition devices to a receiving system.
- Support electronic transmission and management of ECG information in clinical environments.
Clinical Applications
- Transmitting 12-lead ECG recordings from the point of care to a central ECG management or information system.
- Supporting ECG data review and storage in hospitals, emergency departments, cardiology services, and other clinical settings.
- Integrating compatible ECG acquisition equipment with receiving systems used for clinical evaluation.
Practical Considerations
- Compatibility depends on the connected ECG device, communication interfaces, software, and receiving information system; confirm system requirements before installation.
- The transfer station handles ECG data rather than directly recording a patient's ECG or providing treatment.
- Use should follow the manufacturer's instructions for setup, data security, network connectivity, maintenance, and software support.
- This is not an MRI device or an implantable device; MRI compatibility applies to the patient equipment and accessories used in the MRI environment, not automatically to the transfer station.
- The FDA record does not establish a patient-use device size, vascular access requirement, or procedure-specific contraindication.
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 HeartStart 12 Lead Transfer Station used for?
It is used to transfer 12-lead ECG data from the point of care to a central system for analysis and storage.
What specialties typically use this device?
This device is typically used in cardiology and emergency medicine.
What are the FDA-cleared indications?
The device is indicated for transferring ECG data to aid in the diagnosis and monitoring of cardiac conditions.
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.