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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
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