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skyplate detector for philips radiography fluoroscopy systems
Philips Medical Systems Dmc
Summary: The skyplate detector is a component of Philips radiography fluoroscopy systems, primarily used in imaging applications. Key evidence highlights its role in enhancing spatial resolution and reducing artefacts in imaging.
FDA Clearance Information
Pathway
510K
Number
K171461 ↗
Decision Date
July 7, 2017
Product Code
MQB
Device Class
Class 2
Evidence
419 studies
The skyplate detector by Philips Medical Systems was cleared by the FDA through the 510(k) pathway on July 7, 2017. It is classified as a Class 2 device under product code MQB.
What It Is
The skyplate detector is a digital imaging device used in Philips radiography fluoroscopy systems. It functions by capturing high-resolution images, which are crucial for diagnostic purposes in various clinical settings.
Clinical Applications
Commonly used in radiographic and fluoroscopic imaging, the skyplate detector aids in the visualization of anatomical structures, facilitating procedures such as embolization and other interventional radiology applications.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, primarily from 2023 to 2025. These studies focus on the device's imaging capabilities and clinical impact.
Reported Outcomes
Published studies report that the skyplate detector enhances spatial resolution and reduces artefacts in imaging, particularly in coronary and cardiothoracic applications. This improvement aids in the accurate assessment of conditions such as coronary artery disease.
Safety Profile
Reported complications include minimal adverse events, with studies emphasizing the device's safety in clinical use. No significant safety concerns have been highlighted in the available literature.
Evidence Limitations
While the evidence supports the device's efficacy, further research is needed to explore its long-term impact and effectiveness across diverse patient populations. Current studies are limited in scope and sample size.
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 the skyplate detector?
The skyplate detector is indicated for use in radiography and fluoroscopy, particularly in procedures requiring high-resolution imaging, such as embolization and coronary assessments.
What outcomes have been reported in clinical studies?
Studies report improved spatial resolution and reduced imaging artefacts, enhancing diagnostic accuracy in coronary and cardiothoracic imaging.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with no significant complications reported in the studies reviewed.
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.