LAIA XR— 510(k) K251577

Name: FDA 510(k) clearance K251577
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Substantially Equivalent

Augmented Reality Software S.L.

FDA 510(k) clearance K251577 for LAIA XR, Substantially Equivalent on 2026-02-06. Applicant: Augmented Reality Software S.L.. Device class: 2.

Summary

Augmented Reality Software S.L.'s LAIA XR is filed under product code LLZ (System, Image Processing, Radiological). The record doesn't describe the product beyond its name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Augmented Reality Software filed from Salamanca, Spain. Review took 260 calendar days (May 22, 2025 to February 6, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Augmented Reality Software S.L.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-05-22
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salamanca, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263648 — Vitrea Advanced Visualization, Version 7.162026-10-29
K261763 — MIM KineticID2026-10-26
K261531 — PV-iCurve Pro2026-10-21
K261788 — Eden PACS2026-10-21
K263048 — Syngo Carbon Space (VA4)2026-09-29

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.