📋 FDA Reference
Philips Duo Diagnost
Philips Medical Systems North America
Summary: The Philips Duo Diagnost is a versatile imaging system used for diagnostic radiology, primarily by radiologists in hospital settings. It is designed to facilitate a range of imaging procedures, enhancing diagnostic accuracy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K983069 ↗
Decision Date ?
November 2, 1998
Product Code ?
OWB
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Duo Diagnost was cleared through the FDA 510(k) pathway on November 2, 1998, by Philips Medical Systems North America. It is classified as a Class 2 device under product code OWB.
What It Is
The Philips Duo Diagnost is an advanced imaging system that combines fluoroscopy and radiography capabilities. It is designed to provide high-quality images for diagnostic purposes, using X-ray technology to visualize internal structures of the body. This system is particularly useful in capturing dynamic processes, such as swallowing or joint movement, as well as static images for detailed analysis.
FDA-Cleared Indications
- Diagnostic fluoroscopic imaging of internal body structures.
- Radiographic imaging of internal body structures.
- Imaging support for diagnostic examinations in which real-time or static X-ray images are needed.
Clinical Applications
- Fluoroscopic examinations that require real-time visualization of anatomy or motion.
- Radiographic examinations that require static X-ray images.
- Diagnostic imaging of the gastrointestinal tract when fluoroscopy and radiography are indicated.
- Imaging examinations for evaluating bones, joints, and other internal structures.
Practical Considerations
- This is an X-ray system, not an MRI device; it uses ionizing radiation and is not considered MRI safe as a device.
- The system requires appropriate radiation shielding, dose management, quality assurance, and operator training.
- Patient positioning, table weight limits, image-receptor configuration, and available accessories should be verified before an examination.
- Radiographic and fluoroscopic images may be obtained with the patient supine, upright, or in other positions depending on the system configuration and examination.
- Pregnancy status, prior radiation exposure, and the clinical need for contrast media should be assessed according to institutional protocols.
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 Duo Diagnost used for?
The Philips Duo Diagnost is used for diagnostic imaging, providing both fluoroscopy and radiography capabilities to visualize internal body structures.
What specialties typically use this device?
Radiologists and radiologic technologists in hospital and clinical settings primarily use this device for diagnostic imaging.
What are the FDA-cleared indications?
The device is indicated for use in diagnostic imaging to evaluate conditions requiring visualization of internal structures, such as fractures or soft tissue abnormalities.
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.