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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dosimeter, Ionizing Radiation, Implanted
510(k) Number K250083
Device Name PRO-DOSE System
Applicant
Nu-Rise, SA
Creative Science Park
Via Do Conhecimento
Ilhavo,  PT 3830-352
Applicant Contact Joana Melo
Correspondent
Alvamed
935 Great Plain Ave., Suite 166
Needham,  MA  02492
Correspondent Contact Keira Jessop
Regulation Number892.5050
Classification Product Code
NZT  
Subsequent Product Code
IYE  
Date Received01/13/2025
Decision Date 10/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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