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 |