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Autotune Device Atd II Philips S-15 Acs MRI Scan
Medrad
Summary: The Autotune Device ATD II Philips S-15 ACS MRI Scan by Medrad is used in MRI procedures to optimize imaging quality. It is primarily used by radiologists and technicians in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K932403 ↗
Decision Date ?
February 24, 1994
Product Code ?
LNH
Device Class ?
Class 2
Evidence ?
419 studies
The device was cleared through the FDA 510k pathway on February 24, 1994. Manufactured by Medrad, it is classified as a Class 2 device under product code LNH.
What It Is
The Autotune Device ATD II Philips S-15 ACS MRI Scan is a specialized device used in MRI procedures to enhance image quality by automatically tuning the MRI system. It helps in achieving optimal resonance frequency, which is crucial for accurate imaging. This device is particularly useful in complex imaging scenarios where precision is paramount.
FDA-Cleared Indications
- Use with the compatible Philips S-15 ACS MRI system for MRI system tuning or calibration.
- Support MRI image acquisition by optimizing the system's operating parameters.
- Use by trained MRI personnel according to the device and MRI system labeling.
Clinical Applications
- Routine tuning or calibration of a compatible Philips S-15 ACS MRI scanner before or during MRI examinations.
- Supporting MRI examinations when the scanner requires adjustment of operating conditions for image acquisition.
- Use in hospital or radiology-department MRI services by trained radiologists, MRI technologists, or service personnel.
Practical Considerations
- This device is system-specific; verify compatibility with the Philips S-15 ACS MRI system before use.
- The available FDA record does not establish a general indication for use with other MRI scanners or imaging platforms.
- MRI-environment safety must be confirmed from the device labeling and facility MRI safety procedures before bringing the device into the scanner room.
- Setup, tuning, calibration, and troubleshooting should be performed only by trained MRI or service personnel.
- The FDA record provided does not specify patient-contact components, disposable sizes, or a defined service life; consult the current manufacturer documentation for those details.
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 Autotune Device ATD II Philips S-15 ACS MRI Scan used for?
It is used to optimize MRI imaging quality by automatically tuning the MRI system.
What specialties typically use this device?
Radiologists and MRI technicians in hospital radiology departments typically use this device.
What are the FDA-cleared indications?
The device is cleared for optimizing MRI scans, particularly in procedures involving liquid embolization agents.
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.