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philips gyroscan acs-ii release 3
Philips Medical Systems
Summary: The Philips Gyroscan ACS-II Release 3 is an MRI system used for diagnostic imaging. It is primarily used by radiologists and healthcare professionals in hospitals and imaging centers to obtain detailed images of the body's internal structures.
FDA Clearance Information
Pathway
510K
Number
K930709 ↗
Decision Date
November 8, 1993
Product Code
LNH
Device Class
Class 2
Evidence
419 studies
The Philips Gyroscan ACS-II Release 3 was cleared through the FDA 510(k) pathway on November 8, 1993. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code LNH.
What It Is
The Philips Gyroscan ACS-II Release 3 is a magnetic resonance imaging (MRI) system designed to produce high-resolution images of the human body's internal structures. It operates using powerful magnets and radio waves to generate detailed cross-sectional images, aiding in the diagnosis of various medical conditions. This device is essential in non-invasive imaging, offering a safe and effective way to visualize organs, tissues, and other structures without the use of ionizing radiation.
Clinical Applications
This MRI system is commonly used in hospitals and diagnostic imaging centers for a wide range of clinical applications. It is particularly valuable in neurology for brain and spinal cord imaging, in orthopedics for joint and soft tissue evaluation, and in oncology for tumor detection and monitoring. The device is suitable for use in both adult and pediatric populations, providing critical information that guides treatment planning and management across various medical specialties.
Indications for Use
The FDA-cleared indications for the Philips Gyroscan ACS-II Release 3 include its use in obtaining detailed images of the body's internal structures for diagnostic purposes. It is indicated for patients requiring evaluation of neurological, musculoskeletal, and oncological conditions, among others.
Practical Considerations
When using the Philips Gyroscan ACS-II Release 3, clinicians should be aware of the need for patient compatibility with MRI, such as the absence of ferromagnetic implants. Proper positioning and technique are crucial for optimal image quality. The system's compatibility with various coils and sequences allows for tailored imaging protocols based on the clinical question.
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 ACS-II Release 3 used for?
It is used for obtaining high-resolution MRI images to assist in diagnosing various medical conditions.
What specialties typically use this device?
Radiologists and healthcare professionals in neurology, orthopedics, and oncology commonly use this MRI system.
What are the FDA-cleared indications?
It is indicated for diagnostic imaging of internal structures, aiding in the evaluation of neurological, musculoskeletal, and oncological 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.