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philips mx 16 slice ct system phase11 model 9896 056 56511
Philips Medical Systems (Cleveland)
Summary: The Philips MX 16 Slice CT System Phase11 is a computed tomography device used primarily for diagnostic imaging. Key evidence highlights its application in measuring coronary calcium and evaluating hepatic arteries.
FDA Clearance Information
Pathway
510K
Number
K091195 ↗
Decision Date
May 27, 2009
Product Code
JAK
Device Class
Class 2
Evidence
419 studies
The Philips MX 16 Slice CT System Phase11 was cleared by the FDA via the 510(k) pathway on May 27, 2009. It is manufactured by Philips Medical Systems and is classified as a Class 2 device.
What It Is
The Philips MX 16 Slice CT System Phase11 is a multi-slice computed tomography scanner designed for high-resolution imaging. It is intended for use in diagnostic imaging to assess various anatomical structures and pathologies.
Clinical Applications
Common clinical scenarios for this device include evaluating coronary calcium levels, assessing hepatic arterial anatomy, and general diagnostic imaging in various medical conditions.
Evidence Summary
The available literature includes four studies ranging from 2004 to 2022, encompassing retrospective and prospective designs. These studies focus on imaging accuracy, reproducibility, and comparative evaluations.
Reported Outcomes
Published studies report that the Philips MX 16 Slice CT System provides reliable measurements of coronary calcium and is effective in perioperative evaluation of hepatic arteries. The device's imaging capabilities are consistent across different protocols and slice thicknesses.
Safety Profile
Reported complications include potential inaccuracies in noise measurement depending on the region of interest size. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and safety in diverse populations. Further research is needed to explore the device's efficacy in different clinical settings and its comparative performance against newer technologies.
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 MX 16 Slice CT System Phase11?
The device is indicated for diagnostic imaging, including coronary calcium measurement and hepatic artery evaluation.
What outcomes have been reported in clinical studies?
Studies have reported reliable coronary calcium measurements and effective hepatic artery evaluations with the device.
What complications have been reported?
Safety data indicate potential inaccuracies in noise measurement based on region of interest size, with no major adverse events reported.
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.