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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 K250963
Device Name PlanOne 1
Applicant
Cosylab Jsc, Control System Laboratory
Gerbiceva Ulica 64
Ljubljana,  SI 1000
Applicant Contact Matija Rupnik
Correspondent
Cosylab Jsc, Control System Laboratory
Gerbiceva Ulica 64
Ljubljana,  SI 1000
Correspondent Contact Matija Rupnik
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/31/2025
Decision Date 11/20/2025
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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