📋 FDA Reference
Philips Gyroscan T5 Series II
Philips Medical Systems North America
Summary: The Philips Gyroscan T5 Series II is an MRI system used for diagnostic imaging. It is primarily used by radiologists in hospitals and imaging centers to visualize internal structures and diagnose conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K920578 ↗
Decision Date ?
November 6, 1992
Product Code ?
LNH
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Gyroscan T5 Series II was cleared through the FDA 510(k) pathway on November 6, 1992. Manufactured by Philips Medical Systems North America, it is classified as a Class 2 device.
What It Is
The Philips Gyroscan T5 Series II is a magnetic resonance imaging (MRI) system designed to provide high-resolution images of the body's internal structures. It operates using strong magnetic fields and radio waves to generate detailed images, which are crucial for diagnosing a variety of conditions. The system is known for its reliability and precision, making it a valuable tool in medical diagnostics.
FDA-Cleared Indications
- Production of diagnostic images of internal body structures using magnetic resonance imaging.
- Noninvasive imaging to support the evaluation of disease, injury, and other abnormalities.
Clinical Applications
- MRI imaging of the brain and other neurologic structures.
- MRI imaging of the spine.
- MRI imaging of joints and musculoskeletal soft tissues.
- Evaluation of tumors and other abnormalities when MRI is clinically appropriate.
- Diagnostic imaging of soft tissues and internal organs.
Practical Considerations
- MRI safety screening is required before every examination, including evaluation of implanted devices, metal fragments, and other magnetic-field hazards.
- The system requires a dedicated MRI room and appropriate site safety controls, including controlled access and applicable shielding requirements.
- Patients must remain still during image acquisition; motion can reduce image quality and may require repeat sequences.
- The record does not specify the magnet bore size, table weight limit, gradient performance, or available coils; these should be confirmed in the manufacturer's documentation.
- Contraindications and precautions depend on the patient's implants, medical condition, ability to remain still, and any use of contrast material.
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 Gyroscan T5 Series II used for?
It is used for producing high-resolution images of internal body structures, aiding in the diagnosis of various conditions.
What specialties typically use this device?
Radiologists, neurologists, orthopedic surgeons, and oncologists commonly use this MRI system.
What are the FDA-cleared indications?
The device is indicated for diagnostic imaging of internal structures, useful in assessing tumors, neurological disorders, and musculoskeletal injuries.
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.