📊 Evidence-Based Reference
Philips Pixium 4343rc
Philips Medical Systems Dmc
Summary: The Philips Pixium 4343RC is a wireless digital detector used in medical imaging, primarily for embolization procedures. Key evidence highlights its performance in modulation transfer function and contrast-detail analysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131483 ↗
Decision Date ?
October 7, 2013
Product Code ?
MQB
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Pixium 4343RC was cleared by the FDA via the 510(k) pathway on October 7, 2013. It is manufactured by Philips Medical Systems Dmc and classified as a Class 2 device under product code MQB.
What It Is
The Philips Pixium 4343RC is a wireless flat panel detector designed for digital radiography. It is used to capture high-quality images in medical imaging applications, particularly in embolization procedures.
FDA-Cleared Indications
- Acquisition of digital radiographic images for medical diagnosis.
- Use in X-ray imaging systems where a wireless digital detector is compatible with the system.
- Use for image acquisition during procedures such as embolization when incorporated into a compatible imaging system.
Clinical Applications
- Digital X-ray image acquisition
- Portable or mobile radiographic imaging
- Image acquisition during embolization procedures
- Diagnostic imaging with a compatible X-ray system
Evidence Summary
The available literature includes two studies published between 2006 and 2014. These studies involve comparative performance evaluations of flat panel detectors using metrics like modulation transfer function and contrast-detail analysis.
Reported Outcomes
Published studies report that the Philips Pixium 4343RC demonstrates effective performance in modulation transfer function and contrast-detail analysis, indicating its capability in producing high-quality digital images for medical diagnostics.
Safety Profile
Reported complications include no specific adverse events or complications directly associated with the Philips Pixium 4343RC in the provided studies. Safety data is limited in the available literature.
Evidence Limitations
The evidence is limited to two studies, focusing primarily on technical performance metrics. There is a need for further research to evaluate clinical outcomes and long-term safety in diverse patient populations.
Practical Considerations
- The 4343RC designation refers to an approximately 43 × 43 cm detector format; users should confirm the exact active imaging area and system specifications with Philips documentation.
- Wireless operation requires compatibility with the associated X-ray or fluoroscopy system, image-processing software, and wireless communication configuration.
- The detector is intended for X-ray imaging and should not be placed in an MRI scanner unless the manufacturer specifically documents MR compatibility for the exact model and configuration.
- Handle the detector carefully and follow manufacturer limits for weight, impact, cleaning, battery charging, and liquid exposure.
- Use requires appropriate radiation protection and a compatible, approved radiographic imaging system; patient positioning and exposure settings should follow the system's instructions for use.
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 Pixium 4343RC?
The Philips Pixium 4343RC is indicated for use in digital radiography, particularly in procedures involving embolization.
What outcomes have been reported in clinical studies?
Studies report effective performance in modulation transfer function and contrast-detail analysis, highlighting its capability in producing high-quality images.
What complications have been reported?
Safety data from the evidence provided does not report specific complications associated with the Philips Pixium 4343RC.
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.