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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
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