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Philips Lumify Diagnostic Ultrasound System
Philips Healthcare
Summary: The Philips Lumify is a portable diagnostic ultrasound system designed for point-of-care imaging. It is primarily used for vascular and abdominal assessments. Key evidence highlights its feasibility for training and use in diverse clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152899 ↗
Decision Date ?
October 30, 2015
Product Code ?
IYN
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Lumify Diagnostic Ultrasound System was cleared by the FDA through the 510(k) pathway on October 30, 2015. It is manufactured by Philips Healthcare and classified as a Class 2 device under product code IYN.
What It Is
The Philips Lumify is a handheld ultrasound device that connects to a compatible smart device for real-time imaging. It is intended for diagnostic imaging in various clinical applications, including vascular and abdominal assessments.
FDA-Cleared Indications
- Diagnostic ultrasound imaging of the human body.
- Imaging of anatomical structures and blood flow using compatible ultrasound transducers.
- Use in clinical applications for which the selected transducer and software are labeled, including abdominal, vascular, and superficial imaging.
Clinical Applications
- Point-of-care ultrasound assessment in emergency, inpatient, outpatient, and field settings.
- Ultrasound imaging of abdominal organs and structures with an appropriate transducer.
- Ultrasound imaging of superficial organs, tissues, and vessels with an appropriate transducer.
- Doppler assessment of blood flow when supported by the selected transducer and system configuration.
Reported off-label uses
- Ultrasound guidance for peripheral vascular access and other bedside procedures.
- Focused cardiac ultrasound or limited echocardiographic assessment when performed by appropriately trained clinicians.
- Lung ultrasound for bedside assessment of pleural or pulmonary findings.
- Ultrasound assessment of musculoskeletal structures and soft tissues.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, systematic reviews, and performance assessments. The studies span from 2023 to 2025, focusing on the device's feasibility, imaging performance, and clinical applications.
Reported Outcomes
Published studies report that the Philips Lumify is effective in detecting abdominal hemorrhage and assessing vascular conditions. It demonstrates comparable imaging performance to traditional cart-based systems and is feasible for training non-specialist users.
Safety Profile
Reported complications include operator dependency, which may affect reliability in non-clinical settings. No significant adverse events were noted in the reviewed studies, indicating a favorable safety profile.
Evidence Limitations
Evidence gaps include a lack of large-scale studies directly comparing the Philips Lumify to other handheld devices. Further research is needed to explore long-term outcomes and its efficacy in diverse patient populations.
Practical Considerations
- The system uses interchangeable transducers; available imaging capability depends on the transducer, application, software, and compatible smart device.
- It is not a standalone monitor or probe system; the compatible smart device must meet Philips compatibility requirements and run the Lumify application.
- Ultrasound does not use ionizing radiation, but the system is not MRI-compatible equipment and should not be taken into the MRI scanner room unless specifically approved for that environment.
- Image quality and diagnostic performance depend on operator training, patient body habitus, acoustic windows, transducer selection, and device configuration.
- Use should follow the labeling, cleaning and disinfection instructions, electrical-safety requirements, and applicable institutional policies.
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 Lumify Diagnostic Ultrasound System?
The Philips Lumify is indicated for diagnostic imaging in vascular and abdominal assessments, particularly in point-of-care settings.
What outcomes have been reported in clinical studies?
Studies report effective detection of abdominal hemorrhage and vascular conditions, with imaging performance comparable to traditional systems.
What complications have been reported?
Safety data indicate operator dependency as a potential complication, but no significant adverse events have been 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.