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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K251577
Device Name LAIA XR
Applicant
Augmented Reality Software S.L.
Calle Del Adaja 10.
Villamayor
Salamanca,  ES 37185
Applicant Contact Santiago González Izard
Correspondent
Compliance4Devices
118 W Prive Cir
Delray Beach,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/22/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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