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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K230023
Device Name ART-Plan
Applicant
Therapanacea SAS
7 bis boulevard Bourdon
Paris,  FR 75004
Applicant Contact Catherine Martineau-Huynh
Correspondent
Therapanacea SAS
7 bis boulevard Bourdon
Paris,  FR 75004
Correspondent Contact Catherine Martineau-Huynh
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Codes
LLZ   MUJ  
Date Received01/04/2023
Decision Date 04/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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