📋 FDA Reference
Philips RT250 Collimator PK8050
Perkins Mfg.
Summary: The Philips RT250 Collimator PK8050 is a medical device used in radiation therapy to shape and direct x-ray beams. It is primarily used by radiologists and oncologists in therapeutic settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K885126 ↗
Decision Date ?
June 1, 1989
Product Code ?
KQA
Device Class ?
Class 2
Evidence ?
419 studies
The Philips RT250 Collimator PK8050 was cleared through the FDA 510(k) pathway on June 1, 1989. It is manufactured by Perkins Mfg. and classified as a Class 2 device under product code KQA.
What It Is
The Philips RT250 Collimator PK8050 is a device designed to shape and direct x-ray beams during radiation therapy. Collimators are crucial in ensuring that radiation is precisely targeted to minimize exposure to surrounding healthy tissues. This device is particularly useful in therapies requiring high precision, such as minibeam radiation therapy, where it helps in focusing the radiation beams to the intended treatment area.
FDA-Cleared Indications
- Use with compatible 250 kVp x-ray therapy equipment to collimate and shape therapeutic x-ray beams.
- Use during radiation therapy when a defined treatment field is required.
Clinical Applications
- Shaping therapeutic x-ray beams for external-beam radiation treatment.
- Limiting the radiation field to the prescribed treatment area.
- Supporting treatment planning and delivery with compatible 250 kVp x-ray machines.
- Use by radiation oncology teams and medical physicists in appropriately equipped treatment facilities.
Practical Considerations
- Compatibility is specified with 250 kVp x-ray therapy equipment; confirm mechanical, electrical, and radiation-system compatibility before use.
- Proper installation, alignment, calibration, and radiation-output verification are required before clinical treatment.
- The available field sizes and shaping capability should be confirmed from the device documentation and the connected therapy system; they are not established by the FDA record provided here.
- This is an external radiation-treatment accessory, not an implantable or intravascular device.
- MRI safety is not established in the FDA record provided. Do not bring the collimator into an MRI environment unless its MR safety status has been specifically verified.
Related Literature
The linked study titled 'Collimator design for experimental minibeam radiation therapy' focused on designing and optimizing a minibeam collimator for use with a 250 kVp x-ray machine. The study aimed to simulate a synchrotron source for minibeam radiation therapy. Key findings included the potential for improved precision in radiation delivery, though limitations included the experimental nature of the setup and the need for further clinical validation.
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 RT250 Collimator PK8050 used for?
It is used in radiation therapy to shape and direct x-ray beams for precise targeting of treatment areas.
What specialties typically use this device?
Radiation oncologists and medical physicists commonly use this device in therapeutic settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving embolization-liquid-agents, requiring precise radiation targeting.
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.