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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 K234068
Device Name ART-Plan (v.2.2.0)
Applicant
Therapanacea SAS
7 bis boulevard Bourdon
Paris,  FR 75004
Applicant Contact Bhairavi Ajachandra
Correspondent
Therapanacea SAS
7 bis boulevard Bourdon
Paris,  FR 75004
Correspondent Contact Bhairavi Ajachandra
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Codes
LLZ   QKB  
Date Received12/22/2023
Decision Date 04/22/2024
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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