The following data is part of a premarket notification filed by Therapanacea with the FDA for Art-plan.
Device ID | K220813 |
510k Number | K220813 |
Device Name: | ART-PLAN |
Classification | Radiological Image Processing Software For Radiation Therapy |
Applicant | TheraPanacea Pépinière Cochin Paris Santé, 29 Rue Du Faubourg Saint-Jacques Paris, FR 75014 |
Contact | Edwin Lindsay |
Correspondent | Edwin Lindsay TheraPanacea Pépinière Cochin Paris Santé, 29 Rue Du Faubourg Saint-Jacques Paris, FR 75014 |
Product Code | QKB |
Subsequent Product Code | LLZ |
Subsequent Product Code | MUJ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-21 |
Decision Date | 2022-06-17 |