ART-PLAN

Radiological Image Processing Software For Radiation Therapy

TheraPanacea

The following data is part of a premarket notification filed by Therapanacea with the FDA for Art-plan.

Pre-market Notification Details

Device IDK220813
510k NumberK220813
Device Name:ART-PLAN
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant TheraPanacea Pépinière Cochin Paris Santé, 29 Rue Du Faubourg Saint-Jacques Paris,  FR 75014
ContactEdwin Lindsay
CorrespondentEdwin Lindsay
TheraPanacea Pépinière Cochin Paris Santé, 29 Rue Du Faubourg Saint-Jacques Paris,  FR 75014
Product CodeQKB  
Subsequent Product CodeLLZ
Subsequent Product CodeMUJ
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-21
Decision Date2022-06-17

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