📋 FDA Reference
Phillips Omnidiagnost Eleva
Philips Medical Systems
Summary: The Philips OmniDiagnost Eleva is a versatile imaging device used primarily for diagnostic radiology. It is employed by radiologists and healthcare professionals in various clinical settings for imaging and diagnostic purposes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K032046 ↗
Decision Date ?
July 17, 2003
Product Code ?
OWB
Device Class ?
Class 2
Evidence ?
419 studies
The Philips OmniDiagnost Eleva was cleared through the FDA 510(k) pathway on July 17, 2003. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code OWB.
What It Is
The Philips OmniDiagnost Eleva is a radiographic and fluoroscopic imaging system designed to provide high-quality images for diagnostic purposes. It integrates advanced imaging technologies to enhance visualization and improve diagnostic accuracy. The system is equipped with features that allow for flexible positioning and efficient workflow, making it a valuable tool in a clinical setting.
FDA-Cleared Indications
- Diagnostic radiographic imaging
- Fluoroscopic imaging and image-guided examinations
- Imaging of anatomical structures using X-ray and, when clinically appropriate, radiographic contrast media
Clinical Applications
- Gastrointestinal fluoroscopic examinations
- Diagnostic angiographic and vascular imaging
- Orthopedic and musculoskeletal radiography
- General radiographic examinations requiring adjustable patient positioning
- Fluoroscopy-guided diagnostic procedures
Practical Considerations
- This is an X-ray and fluoroscopy system, not an MRI scanner; patients and staff must follow radiation-safety procedures.
- The system may be used with radiographic contrast media when clinically indicated. Contrast selection and administration depend on the examination and the patient's kidney function, allergy history, and other risks.
- Patient positioning, table weight limits, detector configuration, and available accessories should be confirmed before the examination.
- Routine calibration, preventive maintenance, and quality-control testing are needed to maintain image quality and safe operation.
- Use may be inappropriate or require modification in patients who cannot safely tolerate the required positioning, radiation exposure, or contrast administration.
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 is the Philips OmniDiagnost Eleva used for?
The device is used for diagnostic imaging in radiology, including procedures like angiography and gastrointestinal studies.
What specialties typically use this device?
Radiologists and imaging technicians in hospitals and diagnostic centers commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring liquid embolization agents, such as controlling bleeding or blocking blood flow to tumors.
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.