LAIA XR
by Augmented Reality Software S.L. EUDAMED510(k)
Active
510(k) K251577
Overview
The LAIA XR is an augmented reality (AR) imaging system designed for real-time visualization and overlay of medical imaging data. It integrates with radiology workflows to enhance diagnostic accuracy by superimposing digital information onto the patient’s anatomy, facilitating precise surgical planning and intraoperative guidance.
Supplied as a software application, the LAIA XR operates within a radiology setting and is intended for single-use per session, though its reusable nature depends on institutional IT policies. It is not classified as MRI-safe or MRI-conditional, and no specific sterility requirements are stated. Authorized under FDA 510(k) clearance (K251577) and MDR compliance, it adheres to regulatory standards for radiology advisory committee submissions (RA).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK251577 | Date6 Feb 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
How does the LAIA XR integrate into a radiology workflow and what types of medical imaging data can it visualize in real-time?
The LAIA XR is an augmented reality software application designed to overlay digital medical imaging data directly onto a patient’s anatomy during radiology procedures. It enhances diagnostic accuracy and surgical planning by providing real-time visualization of imaging data—such as CT scans, MRI, or X-rays—superimposed on the physical anatomy. This integration helps clinicians make more precise decisions intraoperatively by combining visual and digital information seamlessly within the radiology setting.
Is the LAIA XR meant for repeated use across multiple patients, or is it intended for single-use per session?
The LAIA XR is supplied as a software application intended for single-use per session, though its actual reuse depends on the institutional IT policies of the healthcare facility. Since it is not a physical device with sterility requirements, its operational lifecycle is managed through software licensing and institutional workflows rather than disposable or reusable hardware constraints.
What regulatory pathways does the LAIA XR follow, and how does it align with radiology-specific submissions?
The LAIA XR has been authorized through both FDA 510(k) clearance (K251577) and MDR compliance, confirming its regulatory standing. It was reviewed under the Radiology Advisory Committee (RA) for its submission, which aligns with the product code LLZ—a category designated for radiology advisory committee submissions. This ensures it meets standards for integration into radiology workflows and diagnostic imaging applications.
Does the LAIA XR have any compatibility restrictions with MRI environments, and what should clinicians consider when using it?
The LAIA XR is explicitly not classified as MRI-safe or MRI-conditional, meaning it should not be used in MRI environments. Clinicians should ensure the device is only operated in non-MRI settings, such as standard radiology or surgical theaters, to avoid interference or safety risks. Its use is strictly limited to radiology workflows where MRI compatibility is not required.