đź“‹ FDA Reference
philips gyroscan nt release 6 series
Philips Medical Systems North America
Summary: The Philips Gyroscan NT Release 6 Series is an MRI device used for advanced imaging, particularly in detecting myocardial fibrosis and other cardiac conditions. It is primarily used by radiologists and cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K980645 ↗
Decision Date
May 11, 1998
Product Code
LNH
Device Class
Class 2
Evidence
419 studies
The Philips Gyroscan NT Release 6 Series was cleared through the FDA 510(k) pathway on May 11, 1998. It is manufactured by Philips Medical Systems North America and is classified as a Class 2 medical device.
What It Is
The Philips Gyroscan NT Release 6 Series is a magnetic resonance imaging (MRI) system designed for high-resolution imaging. It utilizes magnetic fields and radio waves to create detailed images of the body's internal structures. This device is particularly useful in cardiac imaging, allowing for the detection of myocardial fibrosis, infarction, and scar tissue through delayed contrast enhancement techniques.
Clinical Applications
This MRI system is commonly used in cardiology and radiology departments for the assessment of cardiac conditions, including hypertrophy and fibrosis. It is particularly valuable in evaluating patients with arterial hypertension to identify myocardial changes. The device is used in hospital settings, often in conjunction with contrast media to enhance image clarity and diagnostic accuracy.
Indications for Use
The FDA-cleared indications for this device include its use in imaging to identify and assess myocardial fibrosis and other cardiac conditions. It is particularly indicated for patients with arterial hypertension who may have underlying cardiac structural changes.
Practical Considerations
The Philips Gyroscan NT Release 6 Series is compatible with standard MRI protocols and contrast agents. Clinicians should be aware of the need for patient preparation, including screening for contraindications to MRI, such as metal implants. Proper training in MRI safety and operation is essential for optimal use.
Related Literature
The linked study investigated the use of cardiac MRI to detect myocardial delayed enhancement in patients with arterial hypertension. The study found that MRI could effectively identify areas of myocardial fibrosis in patients without known coronary disease or previous myocardial infarction. However, the study was limited by its initial sample size and the need for further research to confirm findings across broader 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 is the Philips Gyroscan NT Release 6 Series used for?
It is used for advanced MRI imaging, particularly in detecting myocardial fibrosis and cardiac conditions.
What specialties typically use this device?
Radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for imaging to assess myocardial fibrosis and cardiac conditions, especially in patients with arterial hypertension.
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.