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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
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