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philips epiq diagnostic ultrasound system philips affiniti diagnostic ultrasound system
Philips Medical Systems
Summary: The Philips Epiq and Affiniti diagnostic ultrasound systems are advanced imaging devices used primarily for cardiac and vascular applications. Key evidence highlights their reliability and precision in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K212704 ↗
Decision Date
September 24, 2021
Product Code
IYN
Device Class
Class 2
Evidence
419 studies
The Philips Epiq and Affiniti ultrasound systems were cleared by the FDA via the 510(k) pathway on September 24, 2021. They are manufactured by Philips Medical Systems and classified as Class II devices.
What It Is
The Philips Epiq and Affiniti are diagnostic ultrasound systems designed for high-resolution imaging in various clinical applications, including cardiac and vascular assessments. They utilize advanced imaging technologies to provide detailed anatomical and functional information.
Clinical Applications
These ultrasound systems are commonly used in cardiology for evaluating cardiac function and in vascular medicine for assessing blood flow and vessel integrity. They are also employed in obstetrics for fetal monitoring and in general imaging for soft tissue evaluation.
Evidence Summary
The available literature includes 15 studies, comprising prospective, retrospective, and randomized controlled trials, published between 2021 and 2025. These studies evaluate the performance and precision of the Philips Epiq and Affiniti systems in clinical settings.
Reported Outcomes
Published studies report that the Philips Epiq and Affiniti systems demonstrate high reliability and precision in cardiac imaging. The systems are effective in measuring blood flow velocity and visualizing small anatomical structures, such as fetal adrenal arteries, with high accuracy.
Safety Profile
Reported complications include challenges in standardizing measurements due to anatomical variance, particularly in fetal imaging. No significant adverse events were noted in the studies reviewed.
Evidence Limitations
The evidence highlights the need for further research to standardize measurement techniques and improve imaging precision in complex anatomical regions. Some studies lack large sample sizes, which may limit the generalizability of findings.
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 Epiq and Affiniti ultrasound systems?
These systems are indicated for use in cardiac, vascular, obstetric, and general imaging applications, providing detailed anatomical and functional assessments.
What outcomes have been reported in clinical studies?
Clinical studies have reported high reliability and precision in cardiac imaging, effective blood flow velocity measurements, and accurate visualization of small anatomical structures.
What complications have been reported?
Reported complications include difficulties in standardizing measurements due to anatomical variance, particularly in fetal imaging. No significant adverse events were identified.
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.