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eagle - neodyumium doped yttrium aluminum garnet
Living Technology
Summary: The Eagle is a neodymium-doped yttrium aluminum garnet laser device used in medical procedures, particularly in interventional radiology for y90-radioembolization. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K885257 ↗
Decision Date
June 5, 1989
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The Eagle device was cleared through the FDA 510k pathway on June 5, 1989. Manufactured by Living Technology, it is classified as a Class 2 medical device under product code GEX.
What It Is
The Eagle is a laser device that utilizes neodymium-doped yttrium aluminum garnet (Nd:YAG) technology. It emits a specific wavelength of light that can be used to target tissues with precision. This type of laser is commonly used in medical settings for its ability to deliver controlled energy to specific areas, making it valuable in procedures that require precision and minimal invasiveness.
Clinical Applications
The Eagle device is commonly used in interventional radiology, particularly for procedures like y90-radioembolization, which involves delivering targeted radiation therapy to liver tumors. It is typically used in hospital settings by radiologists or oncologists. The device is suitable for patients with liver cancer or metastatic liver disease, where precise targeting of tumors is crucial.
Indications for Use
The FDA indications for the Eagle device include its use in procedures requiring precise tissue targeting, such as y90-radioembolization. It is primarily indicated for patients with liver tumors, where localized treatment can offer therapeutic benefits.
Practical Considerations
The Eagle device is compatible with standard interventional radiology equipment. Clinicians should be familiar with laser safety protocols and ensure proper calibration before use. The device's settings should be adjusted based on the specific procedure and patient needs.
Frequently Asked Questions
What is Eagle used for?
The Eagle is used for precise tissue targeting in medical procedures, such as y90-radioembolization for liver tumors.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for procedures requiring precise tissue targeting, particularly in treating liver tumors with y90-radioembolization.
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.