đź“‹ FDA Reference
philips cd medical recorder view station dup lication station
Philips Medical Systems North America
Summary: The Philips CD Medical Recorder is a device used for recording and duplicating medical imaging data. It is primarily used by radiologists and medical imaging technicians to manage and distribute imaging records efficiently.
FDA Clearance Information
Pathway
510K
Number
K945460 ↗
Decision Date
March 14, 1995
Product Code
JAA
Device Class
Class 2
Evidence
419 studies
The Philips CD Medical Recorder was cleared through the FDA 510(k) pathway on March 14, 1995. Manufactured by Philips Medical Systems North America, it is classified as a Class 2 device under product code JAA.
What It Is
The Philips CD Medical Recorder is a device designed to record, view, and duplicate medical imaging data onto CDs. It facilitates the storage and sharing of medical images, such as X-rays, MRIs, and CT scans, in a digital format. This device helps streamline the workflow in medical imaging departments by allowing easy access and distribution of imaging data.
Clinical Applications
This device is commonly used in radiology departments and imaging centers where medical imaging data needs to be stored, reviewed, and shared. It is particularly useful in settings where digital imaging is preferred over traditional film, such as in hospitals and outpatient imaging facilities. The device supports clinicians in managing patient imaging records, enhancing the efficiency of diagnostic and treatment planning processes.
Indications for Use
The FDA-cleared indications for this device involve its use in recording and duplicating medical imaging data. It is intended for use in situations where digital storage and distribution of imaging records are necessary, aiding in the management of patient data.
Practical Considerations
The Philips CD Medical Recorder is compatible with standard CD formats, making it easy to integrate into existing imaging systems. Clinicians should ensure that the device is properly calibrated and maintained to ensure optimal performance. It is important to follow the manufacturer's guidelines for use to maximize the device's lifespan and functionality.
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 CD Medical Recorder used for?
The Philips CD Medical Recorder is used for recording, viewing, and duplicating medical imaging data onto CDs, facilitating the storage and sharing of medical images.
What specialties typically use this device?
Radiologists and medical imaging technicians in radiology departments and imaging centers typically use this device.
What are the FDA-cleared indications?
The device is indicated for recording and duplicating medical imaging data, supporting digital storage and distribution of imaging records.
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.