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philips gyroscan intera
Philips Medical Systems North America
Summary: The Philips Gyroscan Intera is an MRI device primarily used for advanced imaging techniques such as diffusion tensor imaging. Key evidence highlights its application in evaluating brain injuries and structural changes.
FDA Clearance Information
Pathway
510K
Number
K992533 ↗
Decision Date
October 18, 1999
Product Code
LNH
Device Class
Class 2
Evidence
419 studies
The Philips Gyroscan Intera was cleared by the FDA through the 510(k) pathway on October 18, 1999. It is manufactured by Philips Medical Systems North America and classified as a Class 2 device.
What It Is
The Philips Gyroscan Intera is a magnetic resonance imaging (MRI) device designed for advanced imaging applications, including diffusion tensor imaging (DTI). It is intended for use in clinical settings to assess and diagnose various neurological and musculoskeletal conditions.
Clinical Applications
Common clinical scenarios for the Philips Gyroscan Intera include evaluating brain injuries, assessing post-radiation changes in bone marrow, and analyzing corticospinal tract characteristics. It provides detailed imaging for diagnostic purposes.
Evidence Summary
The available literature includes 11 studies, comprising case-control studies, RCTs, and other designs, conducted between 2013 and 2023. These studies explore various clinical applications and outcomes associated with the device.
Reported Outcomes
Published studies report that the Philips Gyroscan Intera is effective in identifying changes in brain microstructures, such as lower FA values and higher ADC values in patients with brain injuries. It also aids in analyzing post-radiation bone marrow changes and corticospinal tract characteristics.
Safety Profile
Reported complications include no specific adverse events or complications directly linked to the Philips Gyroscan Intera in the provided evidence. The studies primarily focus on imaging outcomes rather than safety profiles.
Evidence Limitations
The evidence is limited by the small sample sizes and the focus on specific clinical scenarios. Further research is needed to explore broader applications and long-term safety outcomes of the Philips Gyroscan Intera.
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 are the clinical indications for Philips Gyroscan Intera?
The device is indicated for advanced imaging in neurological and musculoskeletal assessments, including brain injuries and post-radiation changes.
What outcomes have been reported in clinical studies?
Studies report effective imaging of brain microstructures and post-radiation bone marrow changes, with specific findings on FA and ADC values.
What complications have been reported?
No specific complications have been reported in the provided evidence. The focus is primarily on imaging outcomes.
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.