📋 FDA Reference
Philips Mammodiagnost Bc
Philips Medical Systems
Summary: The Philips MammoDiagnost BC is a mammography device used for breast imaging to detect abnormalities. It is primarily used by radiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K913845 ↗
Decision Date ?
December 20, 1991
Product Code ?
IZH
Device Class ?
Class 2
Evidence ?
419 studies
The Philips MammoDiagnost BC was cleared through the FDA 510k pathway on December 20, 1991. It is manufactured by Philips Medical Systems and is classified as a Class 2 device.
What It Is
The Philips MammoDiagnost BC is a specialized imaging device designed for mammography, which is the process of using low-energy X-rays to examine the human breast. It assists in the early detection and diagnosis of breast diseases in women. The device works by capturing detailed images of breast tissue, allowing radiologists to identify potential abnormalities such as tumors or cysts.
FDA-Cleared Indications
- Mammographic imaging of the breast for the detection of breast abnormalities.
Clinical Applications
- Routine mammography screening in eligible patients.
- Diagnostic mammography after a breast symptom, clinical finding, or screening abnormality.
- Evaluation of suspicious breast findings, including masses, calcifications, or areas of distortion.
- Follow-up imaging of a previously identified breast abnormality when mammography is clinically indicated.
Practical Considerations
- The breast is positioned and compressed between dedicated mammography surfaces to produce diagnostic images and reduce motion.
- This is an X-ray device, not an MRI system; MRI safety labeling does not apply, although the system and room may have site-specific safety requirements.
- Patients should tell the technologist if they are pregnant or might be pregnant, have breast implants, or have significant breast tenderness.
- Image quality depends on correct positioning, compression, exposure settings, and regular equipment calibration and maintenance.
- The system is intended for use by trained mammography personnel and requires interpretation by a qualified clinician.
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 MammoDiagnost BC used for?
The Philips MammoDiagnost BC is used for mammography, which involves breast imaging to detect abnormalities such as tumors or cysts.
What specialties typically use this device?
Radiologists and breast imaging specialists typically use this device in clinical settings for breast cancer screening and diagnosis.
What are the FDA-cleared indications?
The device is cleared for use in breast imaging to detect breast abnormalities in patients undergoing screening or 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.