đź“Š Evidence-Based Reference
philips epiq 5 diagnostic ultrasound system epiq 7 diagnostic ultrasound system affiniti 30 diagnostic ultrasound system affiniti 50 diagnostic ultrasound system affiniti 70 diagnostic ultrasound system
Philips Health Care
Summary: The Philips EPIQ and Affiniti ultrasound systems are advanced diagnostic tools used primarily for imaging in various clinical settings. Key evidence highlights their reliability in measuring stenosis and diagnosing postpartum urinary retention.
FDA Clearance Information
Pathway
510K
Number
K172607 ↗
Decision Date
October 4, 2017
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 October 4, 2017. They are manufactured by Philips Health Care and classified as Class II devices.
What It Is
The Philips EPIQ and Affiniti ultrasound systems are diagnostic imaging devices designed for a wide range of clinical applications, including cardiovascular, obstetric, and gynecological imaging. They utilize advanced ultrasound technology to provide high-resolution images for accurate diagnosis.
Clinical Applications
These ultrasound systems are commonly used in clinical scenarios such as evaluating carotid artery stenosis, assessing fetal well-being in high-risk pregnancies, and diagnosing postpartum urinary retention. They provide critical imaging support in both routine and complex cases.
Evidence Summary
The available literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2023 to 2024, providing a comprehensive overview of the systems' clinical efficacy and safety.
Reported Outcomes
Published studies report high reliability in measuring carotid artery stenosis and diagnosing postpartum urinary retention with near-perfect agreement rates. The systems have shown efficacy in predicting fetal outcomes in high-risk pregnancies using advanced Doppler techniques.
Safety Profile
Reported complications include minimal adverse events, with no significant safety concerns highlighted in the reviewed studies. The devices are generally considered safe for routine clinical use.
Evidence Limitations
The evidence base is limited by the relatively short time frame of the studies and the need for larger sample sizes to confirm findings. Further research is needed to explore long-term outcomes and potential device-specific limitations.
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 ultrasound systems?
Philips ultrasound systems are indicated for use in cardiovascular, obstetric, and gynecological imaging, among other applications.
What outcomes have been reported in clinical studies?
Studies have reported high reliability in measuring stenosis and diagnosing postpartum urinary retention, with strong agreement and correlation rates.
What complications have been reported?
Reported complications include minimal adverse events, with no significant safety concerns noted in the reviewed studies.
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.