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philips computed radiography system pcr
Parexel Intl.
Summary: The Philips Computed Radiography System PCR, manufactured by Parexel Intl., is a radiographic imaging device cleared by the FDA. It is primarily used for diagnostic imaging in various clinical settings. Key evidence highlights its role in assessing treatment responses and lung involvement in COVID-19.
FDA Clearance Information
Pathway
510K
Number
K864519 ↗
Decision Date
February 13, 1987
Product Code
LLZ
Device Class
Class 2
Evidence
419 studies
The Philips Computed Radiography System PCR was cleared by the FDA through the 510(k) pathway on February 13, 1987. It is manufactured by Parexel Intl. and classified as a Class 2 device under product code LLZ.
What It Is
The Philips Computed Radiography System PCR is a medical imaging device that uses computed radiography technology to capture and process digital radiographic images. It is intended for use in diagnostic imaging to assist clinicians in evaluating and diagnosing various medical conditions.
Clinical Applications
Common clinical scenarios for this device include diagnostic imaging for evaluating treatment responses in cancer therapy and assessing lung involvement in COVID-19 pneumonia. It provides high-quality images that aid in clinical decision-making.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2022 to 2025, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report the device's efficacy in evaluating treatment responses, such as pathologic complete response in breast cancer, with AUC values ranging from 0.803 to 0.84. It is also used for assessing lung involvement in COVID-19, aiding in prognosis and treatment planning.
Safety Profile
Reported complications include minimal adverse events, with no significant safety concerns highlighted in the available studies. The device is generally considered safe for clinical use.
Evidence Limitations
Evidence gaps include the need for more extensive studies to validate findings across diverse populations. Some studies have limitations in sample size and design, necessitating further research to confirm efficacy and safety.
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 Computed Radiography System PCR?
The device is indicated for diagnostic imaging in various clinical scenarios, including cancer treatment response evaluation and lung assessment in COVID-19.
What outcomes have been reported in clinical studies?
Studies report effective evaluation of treatment responses, such as pathologic complete response in breast cancer, with AUC values indicating high diagnostic accuracy.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with no significant complications reported in the studies reviewed.
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.