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aida with dicom and hl7 interface
Karl Storz Endoscopy-America
Summary: The aida with DICOM and HL7 interface is a medical device used for managing and integrating imaging data during surgical procedures. It is primarily used by surgeons and clinical staff in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K043324 ↗
Decision Date
April 4, 2005
Product Code
FET
Device Class
Class 2
Evidence
0 studies
The aida with DICOM and HL7 interface was cleared through the FDA 510(k) pathway on April 4, 2005. Manufactured by Karl Storz Endoscopy-America, it is classified as a Class 2 device under product code FET.
What It Is
The aida with DICOM and HL7 interface is a medical device designed to facilitate the management and integration of imaging data in surgical settings. It supports the DICOM standard for handling, storing, and transmitting medical images, as well as the HL7 standard for electronic health information exchange. This device enhances the workflow in operating rooms by allowing seamless communication between imaging modalities and hospital information systems.
Clinical Applications
This device is commonly used in surgical specialties such as general surgery, urology, and gynecology, where real-time imaging data is crucial. It is particularly valuable in minimally invasive procedures, where precise imaging guidance is required. The aida system is typically employed in hospital operating rooms and ambulatory surgical centers, serving a wide range of patient populations undergoing surgical interventions.
Indications for Use
The aida with DICOM and HL7 interface is indicated for use in managing and integrating imaging data during surgical procedures. It is suitable for patients undergoing surgeries where imaging data needs to be accessed and transmitted efficiently.
Practical Considerations
Clinicians should ensure compatibility with existing hospital information systems and imaging modalities. The device typically integrates with standard DICOM and HL7 protocols, making it versatile for various surgical environments. Proper training on its interface and functionalities is recommended for optimal use.
Frequently Asked Questions
What is aida with DICOM and HL7 interface used for?
It is used for managing and integrating imaging data during surgical procedures, enhancing communication between imaging systems and hospital information systems.
What specialties typically use this device?
Specialties such as general surgery, urology, and gynecology commonly use this device, particularly in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for managing and integrating imaging data during surgeries, facilitating efficient access and transmission of imaging information.
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.