📊 Evidence-Based Reference
Philips Essenta Dr
Philips Medical Systems Gmbh, Dmc
Summary: The Philips Essenta DR is a digital radiography system primarily used for diagnostic imaging. Key evidence highlights its role in diagnosing pneumoconiosis with consistent results compared to high-kV radiographs.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K070528 ↗
Decision Date ?
March 9, 2007
Product Code ?
MQB
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Essenta DR was cleared by the FDA through the 510(k) pathway on March 9, 2007. It is manufactured by Philips Medical Systems Gmbh and classified as a Class 2 device.
What It Is
The Philips Essenta DR is a digital radiography system designed for capturing high-quality diagnostic images. It is intended for use in various clinical settings to assist in the diagnosis of conditions such as pneumoconiosis.
FDA-Cleared Indications
- Digital radiographic imaging for diagnostic purposes.
- Radiographic examination of the chest and other anatomical regions.
- Imaging to assist in the evaluation of pneumoconiosis and other conditions requiring plain-film radiography.
Clinical Applications
- Chest radiographs.
- Plain radiographs of other body regions when clinically indicated.
- Diagnostic imaging for evaluating suspected or known pneumoconiosis.
- General radiology examinations in hospital and outpatient imaging departments.
Evidence Summary
The available literature includes two studies from 2013, focusing on the diagnostic capabilities of digital radiography in pneumoconiosis. These studies explore image processing parameters and consistency with high-kV radiographs.
Reported Outcomes
Published studies report that the Philips Essenta DR provides consistent diagnostic results for pneumoconiosis when compared to high-kV chest radiographs. The studies emphasize its reliability in clinical settings.
Safety Profile
Reported complications include no specific adverse events or safety concerns directly associated with the use of the Philips Essenta DR in the provided studies.
Evidence Limitations
The evidence is limited to two studies focusing on pneumoconiosis, with a need for broader research on other conditions. Further studies could enhance understanding of its full clinical utility.
Practical Considerations
- The system uses ionizing radiation and should be operated by trained radiology personnel using protocols that balance image quality with radiation exposure.
- It is a diagnostic X-ray system, not an MRI system; the room and equipment should be managed according to site-specific radiation-safety requirements.
- Image quality depends on detector configuration, positioning, exposure technique, collimation and routine quality-control testing.
- Compatibility with replacement detectors, workstations, accessories and image-archiving systems should be confirmed with the manufacturer or qualified service provider.
- The FDA record identifies the device as a Class II product cleared through the 510(k) pathway under product code MQB.
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 Essenta DR?
The Philips Essenta DR is indicated for diagnostic imaging, particularly in evaluating respiratory conditions such as pneumoconiosis.
What outcomes have been reported in clinical studies?
Studies report consistent diagnostic results for pneumoconiosis, comparable to high-kV radiographs.
What complications have been reported?
No specific complications or adverse events have been reported in the provided 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.