đź“Š Evidence-Based Reference
Philips Incisive CT
Philips Healthcare (Suzhou)
Summary: The Philips Incisive CT is a computed tomography device used primarily for diagnostic imaging. Key evidence highlights its efficacy in low-dose imaging protocols and AI-enhanced image quality.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180015 ↗
Decision Date ?
March 20, 2018
Product Code ?
JAK
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Incisive CT received FDA clearance through the 510(k) pathway on March 20, 2018. It is manufactured by Philips Healthcare (Suzhou) and classified as a Class 2 device.
What It Is
The Philips Incisive CT is a computed tomography scanner designed for diagnostic imaging across various clinical applications. It utilizes advanced reconstruction algorithms to enhance image quality while minimizing radiation exposure.
FDA-Cleared Indications
- Computed tomography imaging for diagnostic evaluation of the head, body, and extremities.
- Imaging of adults and pediatric patients when a CT examination is clinically indicated.
- Production, display, storage, and transfer of CT images for interpretation by qualified healthcare professionals.
Clinical Applications
- CT examinations of the brain and other head structures.
- CT imaging of the chest and lungs.
- CT imaging of the abdomen and pelvis, including evaluation of hepatobiliary conditions.
- Low-dose CT protocols when clinically appropriate and supported by the examination protocol.
- CT evaluation of the extremities and other body regions.
Reported off-label uses
- CT-based procedural planning and image guidance may be used in clinical practice, depending on the scanner configuration, software, institutional protocols, and applicable labeling.
- Quantitative imaging and research applications may be performed under appropriate institutional oversight but are not necessarily cleared diagnostic indications.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 11 studies, comprising RCTs, prospective, and retrospective analyses, published between 2024 and 2025. These studies focus on imaging quality and radiation dose reduction.
Reported Outcomes
Published studies report that the Philips Incisive CT effectively reduces radiation dose while maintaining high image quality. The use of deep learning algorithms further enhances image reconstruction, particularly in low-dose protocols.
Safety Profile
Reported complications include concerns about contrast-induced nephropathy, although no specific adverse events are detailed in the provided studies. Overall, the device is considered safe with appropriate use.
Evidence Limitations
The evidence is limited by the short date range of studies and the lack of large-scale, long-term outcome data. Further research is needed to explore the device's efficacy in diverse clinical populations.
Practical Considerations
- The system uses ionizing radiation; examination settings should be selected according to the patient, body region, and diagnostic task.
- It is not an MRI system and is not used for MRI examinations. Patients with implanted devices should still be screened according to the facility's CT, contrast, and radiation-safety protocols.
- Patient table weight limits, gantry dimensions, detector configuration, and available software depend on the specific system configuration and installation.
- When iodinated contrast is planned, assess allergy history, kidney function, pregnancy status, and other facility-specific contraindications.
- CT images should be acquired and interpreted by trained staff using the manufacturer's instructions and applicable institutional protocols.
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 Incisive CT?
The Philips Incisive CT is indicated for diagnostic imaging in thoracic, brain, and abdominal applications, particularly where low-dose protocols are beneficial.
What outcomes have been reported in clinical studies?
Studies report effective radiation dose reduction and enhanced image quality using advanced reconstruction algorithms.
What complications have been reported?
Safety data indicate potential concerns about contrast-induced nephropathy, though specific adverse events are not detailed.
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.