📋 FDA Reference
Philips Incisive CT on Trailer
Philips Healthcare (Suzhou)
Summary: The Philips Incisive CT on Trailer is a mobile computed tomography system used for diagnostic imaging. It's primarily utilized by radiologists and healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211168 ↗
Decision Date ?
November 22, 2021
Product Code ?
JAK
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Incisive CT on Trailer was cleared via the FDA 510(k) pathway on November 22, 2021. Manufactured by Philips Healthcare (Suzhou), it is classified as a Class 2 medical device.
What It Is
The Philips Incisive CT on Trailer is a mobile CT imaging system designed to provide high-quality diagnostic imaging in a flexible, transportable format. It integrates advanced imaging technology with the convenience of mobility, allowing for deployment in diverse healthcare environments. The system is equipped with features that optimize image quality and reduce radiation exposure, enhancing patient safety and diagnostic accuracy.
FDA-Cleared Indications
- Diagnostic computed tomography imaging of the body.
- Acquisition of cross-sectional images to support diagnosis and clinical management.
Clinical Applications
- Routine diagnostic CT imaging of the head, neck, chest, abdomen, pelvis, and extremities.
- Evaluation of suspected acute disease or injury when cross-sectional imaging is clinically indicated.
- Imaging performed in hospitals, outpatient facilities, emergency departments, or other appropriately equipped clinical settings.
- CT examinations performed with or without intravenous contrast when ordered and clinically appropriate.
Practical Considerations
- This is a mobile CT system mounted on a trailer; the installation site requires appropriate space, power, environmental controls, radiation shielding, and structural access.
- CT uses ionizing radiation. The examination should be justified and optimized, particularly in children, pregnant patients, and patients requiring repeated scans.
- Intravenous contrast may be used for selected studies, but contrast administration requires screening for allergy risk, kidney function, and other contraindications.
- The system is not an MRI scanner and is not MRI-safe as a device category; patients and staff must follow site-specific MRI safety rules when CT and MRI services are located together.
- Image acquisition and interpretation require trained radiology personnel, appropriate protocols, and integration with the facility's imaging and information systems.
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 Incisive CT on Trailer used for?
It is used for diagnostic imaging to obtain detailed cross-sectional images of the body, aiding in the diagnosis of various medical conditions.
What specialties typically use this device?
Radiologists and emergency physicians commonly use this device in hospitals, outpatient imaging centers, and emergency settings.
What are the FDA-cleared indications?
The device is indicated for diagnostic imaging in conditions requiring detailed visualization of internal structures, such as vascular conditions and tumors.
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.