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philips gyroscan t5 ii release 3
Philips Medical Systems
Summary: The Philips Gyroscan T5 II Release 3 is an MRI system used for diagnostic imaging. It is primarily utilized by radiologists for assessing various medical conditions through detailed imaging of internal structures.
FDA Clearance Information
Pathway
510K
Number
K930708 ↗
Decision Date
January 25, 1994
Product Code
LNH
Device Class
Class 2
Evidence
419 studies
The Philips Gyroscan T5 II Release 3 was cleared by the FDA via the 510k pathway on January 25, 1994. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code LNH.
What It Is
The Philips Gyroscan T5 II Release 3 is a magnetic resonance imaging (MRI) system designed to provide high-resolution images of the body's internal structures. It operates by using strong magnetic fields and radio waves to generate detailed images, which are crucial for diagnosing a wide range of medical conditions. This device is part of the advanced imaging technology that aids clinicians in visualizing soft tissues, organs, and other internal body parts without the use of ionizing radiation.
Clinical Applications
This MRI system is commonly used in hospitals and diagnostic imaging centers for a variety of clinical scenarios, including neurological, musculoskeletal, and cardiovascular imaging. It is particularly valuable in specialties such as radiology, neurology, and orthopedics. The device is used to assess conditions like brain tumors, spinal cord injuries, joint abnormalities, and vascular diseases, providing critical information for treatment planning.
Indications for Use
The FDA indications for the Philips Gyroscan T5 II Release 3 include its use in obtaining detailed images of the body's internal structures, which is essential for diagnosing and monitoring various medical conditions. It is suitable for patients requiring non-invasive imaging for conditions affecting the brain, spine, joints, and other soft tissues.
Practical Considerations
When using the Philips Gyroscan T5 II Release 3, clinicians should be aware of the typical MRI safety protocols, including screening for metal implants and ensuring patient comfort during the procedure. The device is compatible with standard MRI-compatible accessories and requires routine maintenance to ensure optimal performance.
Related Literature
The linked study investigated changes in intracranial volume following the cross-clamping of the descending thoracic aorta in pigs, using MRI technology. The study aimed to understand the physiological effects of aortic cross-clamping on brain volume, which is relevant for surgical procedures involving the aorta. Key findings indicated potential alterations in intracranial volume, highlighting the importance of monitoring such changes during surgery. However, the study's limitations include its animal model, which may not fully translate to human physiology.
Linked Studies (20)
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Clinical progress note: Haemophilus influenzae type b.
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Pilot study of social media promotion of home-based self-testing for syphilis.
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
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pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
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Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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
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PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
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A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips Gyroscan T5 II Release 3 used for?
It is used for obtaining detailed MRI images of the body's internal structures, aiding in the diagnosis and monitoring of various medical conditions.
What specialties typically use this device?
Radiology, neurology, and orthopedics are the primary specialties that utilize this MRI system for diagnostic imaging.
What are the FDA-cleared indications?
The device is indicated for producing high-resolution images of internal body structures, useful for diagnosing conditions affecting the brain, spine, joints, and soft tissues.
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.