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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K242418
Device Name P-Cure Proton Therapy System (PPTS)
Applicant
P-Cure, Ltd.
14 Carmel St.
Shilat Industrial Zone,  IL 7318800
Applicant Contact Ori Lubin
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number892.5050
Classification Product Code
LHN  
Date Received08/15/2024
Decision Date 05/12/2025
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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