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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 K202700
Device Name ART-Plan
Applicant
TheraPanacea
Pepiniere Cochin Paris Sante
29 Rue du Faubourg Saint-Jacques
Paris,  FR 75014
Applicant Contact Edwin Lindsay
Correspondent
TheraPanacea
Pepiniere Cochin Paris Sante
29 Rue du Faubourg Saint-Jacques
Paris,  FR 75014
Correspondent Contact Edwin Lindsay
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Code
LLZ  
Date Received09/16/2020
Decision Date 01/14/2021
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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