đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Management and integration of imaging data during surgical procedures.
- Use with compatible imaging systems and hospital information systems through DICOM and HL7 interfaces.
Clinical Applications
- Displaying and managing surgical images and video during procedures.
- Transmitting medical images using the DICOM standard.
- Exchanging related health information with compatible systems using the HL7 standard.
- Integrating imaging equipment and information systems in an operating-room environment.
Practical Considerations
- Compatibility with the facility's imaging equipment, DICOM configuration, HL7 interface, network, and electronic health record should be confirmed before use.
- The system is not itself a diagnostic imaging modality or an implantable device; clinical decisions depend on the connected equipment and qualified users.
- MRI safety depends on the specific components, cables, displays, carts, and accessories. The system should not be brought into an MRI environment unless each component is specifically labeled for that environment.
- User training, cybersecurity controls, data backup, and appropriate handling of protected health information are important for safe operation.
- The FDA record identifies a Class II device cleared through the 510(k) pathway under product code FET; the record provided does not specify patient-size limits or implantable-device dimensions.
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.