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olympus lyophilized calibrator models dr0070 and dr0071
Olympus America
Summary: The Olympus Lyophilized Calibrator models DR0070 and DR0071 are used in medical settings for calibration purposes, particularly in procedures involving embolization liquid agents. These devices are typically utilized by healthcare professionals in radiology and interventional specialties.
FDA Clearance Information
Pathway
510K
Number
K032665 ↗
Decision Date
November 21, 2003
Product Code
JIX
Device Class
Class 2
Evidence
419 studies
The Olympus Lyophilized Calibrator received FDA clearance through the 510(k) pathway on November 21, 2003. Manufactured by Olympus America, it is classified as a Class 2 device under product code JIX.
What It Is
The Olympus Lyophilized Calibrator is a medical device designed to assist in the calibration of equipment used in procedures involving embolization liquid agents. These calibrators ensure that the equipment functions accurately, which is crucial for the precise delivery of embolic materials. The lyophilized nature of the calibrator allows for stability and ease of storage, making it a reliable component in clinical settings.
Clinical Applications
This device is commonly used in interventional radiology and other specialties that perform embolization procedures, such as oncology and vascular surgery. It is particularly relevant in settings where precise calibration of embolization equipment is necessary to ensure accurate delivery of therapeutic agents. The calibrator is used in hospitals and specialized clinics, often involving patients with conditions requiring targeted embolization therapy.
Indications for Use
The FDA-cleared indications suggest that the device is intended for use in the calibration of equipment used in embolization procedures. This is relevant for patients undergoing treatment for conditions such as tumors or vascular malformations, where precise delivery of embolic agents is critical.
Practical Considerations
The Olympus Lyophilized Calibrator is typically compatible with a range of embolization equipment. Clinicians should ensure the calibrator is properly reconstituted before use. It is important to follow the manufacturer's guidelines for storage and handling to maintain its efficacy.
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 Olympus Lyophilized Calibrator used for?
It is used for calibrating equipment in procedures involving embolization liquid agents to ensure accurate delivery.
What specialties typically use this device?
Interventional radiology, oncology, and vascular surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in calibrating equipment used in embolization procedures, ensuring precise delivery of embolic agents.
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.