đź“‹ FDA Reference

philips ultrasound p800 imaging system

Hewlett-Packard

Summary: The Philips Ultrasound P800 Imaging System is a diagnostic imaging device used primarily for ultrasound examinations. It is utilized by radiologists and other specialists to assess various medical conditions.

FDA Clearance Information

Pathway 510K
Decision Date December 8, 1994
Product Code IYN
Device Class Class 2
Evidence 419 studies

The Philips Ultrasound P800 Imaging System was cleared through the FDA 510k pathway on December 8, 1994. It is manufactured by Hewlett-Packard and classified as a Class 2 device under product code IYN.

What It Is

The Philips Ultrasound P800 Imaging System is a medical imaging device that uses high-frequency sound waves to produce images of structures within the body. It is designed to assist clinicians in diagnosing and monitoring a wide range of conditions by providing real-time, detailed images. The system is versatile and can be used in various clinical settings, offering features that enhance image quality and diagnostic accuracy.

Clinical Applications

This ultrasound system is commonly used in radiology, cardiology, and obstetrics/gynecology. It is suitable for both inpatient and outpatient settings, providing imaging for procedures such as abdominal scans, cardiac assessments, and prenatal evaluations. The device is particularly useful in evaluating soft tissues, organs, and blood flow, making it a critical tool in diagnosing conditions like tumors, vascular diseases, and fetal development issues.

Indications for Use

The FDA-cleared indications for the Philips Ultrasound P800 Imaging System include its use in diagnostic imaging to evaluate and monitor conditions involving soft tissues, organs, and blood flow. It is suitable for patients requiring non-invasive imaging for diagnostic purposes.

Practical Considerations

The Philips Ultrasound P800 is compatible with a variety of transducers, allowing for flexibility in imaging different body parts. Clinicians should be familiar with the system's interface and settings to optimize image quality. Regular maintenance and calibration are recommended to ensure accurate performance.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 Ultrasound P800 Imaging System used for?

It is used for diagnostic imaging to assess and monitor conditions involving soft tissues, organs, and blood flow.

What specialties typically use this device?

Radiology, cardiology, and obstetrics/gynecology are the primary specialties that use this device.

What are the FDA-cleared indications?

The device is indicated for use in diagnostic imaging to evaluate and monitor conditions involving soft tissues, organs, and blood flow.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.