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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K252784
Device Name eXaSkin Plus
Applicant
Anatomical Geometry S.L.
Parque Industrial Y De Servicio Aljarafe
C/ Formación Nº6, 41927
Mairena Del Aljarafe,  ES
Applicant Contact Eduardo Suarez
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Tyler Ting
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
IXI  
Date Received09/02/2025
Decision Date 05/22/2026
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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