📋 FDA Reference
Philips M2424 Diagnostic Ultrasound System Philips 21315 Diagnostic Ultrasound Transducer
Philips Ultrasound
Summary: The Philips M2424 Diagnostic Ultrasound System, paired with the Philips 21315 Transducer, is used for diagnostic imaging in various medical settings. It is primarily utilized by radiologists and sonographers for non-invasive imaging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022303 ↗
Decision Date ?
July 30, 2002
Product Code ?
IYN
Device Class ?
Class 2
Evidence ?
419 studies
The Philips M2424 Diagnostic Ultrasound System was cleared through the FDA's 510(k) pathway on July 30, 2002. Manufactured by Philips Ultrasound, it is classified as a Class II device under product code IYN.
What It Is
The Philips M2424 is a diagnostic ultrasound system designed for non-invasive imaging. It uses high-frequency sound waves to produce images of organs and tissues inside the body. The system is equipped with the Philips 21315 transducer, which facilitates the conversion of electrical energy into sound waves and vice versa, allowing for detailed imaging. This device is commonly used in hospitals and clinics for diagnostic purposes.
FDA-Cleared Indications
- Diagnostic ultrasound imaging of the human body using the compatible transducer.
- Evaluation of organs, tissues, and anatomical structures that can be examined with diagnostic ultrasound.
- Imaging applications in which ultrasound is used to assess tissue appearance and, when supported by the system and transducer, motion or blood flow.
Clinical Applications
- General diagnostic ultrasound imaging of soft tissues and internal organs.
- Ultrasound evaluation during obstetric and prenatal care when the system is configured with an appropriate transducer.
- Cardiac or vascular imaging when supported by the selected transducer and system configuration.
- Inpatient or outpatient diagnostic examinations performed by trained healthcare professionals.
Practical Considerations
- The Philips 21315 is a transducer used with the M2424 system; imaging capability depends on the transducer type, frequency, software, and system configuration.
- Ultrasound does not use ionizing radiation and is not performed inside an MRI scanner. The system and transducer should be kept outside the MRI environment unless the specific equipment is separately labeled for MRI use.
- Examinations should be performed by trained personnel using appropriate acoustic output, infection-control procedures, and transducer handling practices.
- Image quality can be limited by bone, air, obesity, dressings, wounds, or other tissues that interfere with sound transmission.
- Routine inspection, cleaning, disinfection, maintenance, and calibration should follow the manufacturer's instructions and the intended level of patient contact.
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 M2424 Diagnostic Ultrasound System used for?
It is used for non-invasive diagnostic imaging of organs and tissues, including blood flow assessment.
What specialties typically use this device?
Radiologists, cardiologists, and obstetricians commonly use this ultrasound system.
What are the FDA-cleared indications?
The device is indicated for diagnostic imaging, including evaluating blood flow and detecting organ and tissue abnormalities.
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.