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 Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/16/2020 |
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
|
|
|