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cytoguide for use w the philmedisyst mammodiag uc
Philips Medical Systems North America
Summary: The Cytoguide for use with the Mammodiag UC is a medical device used in conjunction with mammography systems for diagnostic procedures. It is primarily used by radiologists and healthcare professionals in breast imaging centers.
FDA Clearance Information
Pathway
510K
Number
K896609 ↗
Decision Date
January 31, 1990
Product Code
IZH
Device Class
Class 2
Evidence
419 studies
The Cytoguide for use with the Mammodiag UC was cleared through the FDA 510(k) pathway on January 31, 1990. It is manufactured by Philips Medical Systems North America and classified as a Class 2 device under product code IZH.
What It Is
The Cytoguide is an accessory designed for use with the Mammodiag UC, a mammography diagnostic system. It assists in the precise localization and guidance of instruments during breast imaging procedures. This device enhances the accuracy of diagnostic interventions, particularly in identifying and targeting suspicious areas within breast tissue.
Clinical Applications
The Cytoguide is commonly used in breast imaging centers and radiology departments during mammographic procedures. It is particularly valuable in procedures such as biopsies and needle localizations, where precise targeting of breast lesions is critical. The device is used by radiologists and trained technicians to improve diagnostic accuracy and patient outcomes in breast cancer screening and diagnosis.
Indications for Use
The FDA indications for the Cytoguide involve its use in enhancing the precision of mammographic procedures. It is intended for patients undergoing diagnostic evaluations of breast tissue, particularly when suspicious lesions are identified during screening.
Practical Considerations
The Cytoguide is compatible with the Mammodiag UC system and typically requires specific training for optimal use. Clinicians should ensure proper calibration and positioning to maximize its effectiveness during procedures. It is important to follow manufacturer guidelines for maintenance and operation.
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
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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
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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 Cytoguide used for?
The Cytoguide is used to assist in precise localization and guidance during mammographic procedures, such as biopsies and needle localizations.
What specialties typically use this device?
Radiologists and breast imaging specialists typically use the Cytoguide in breast imaging centers and radiology departments.
What are the FDA-cleared indications?
The Cytoguide is indicated for use in enhancing the precision of mammographic procedures, particularly in targeting suspicious breast lesions for diagnostic evaluation.
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.