The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Contour Protégéai.
| Device ID | K213976 |
| 510k Number | K213976 |
| Device Name: | Contour ProtégéAI |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | MIM Software Inc. 25800 Science Park Drive – Suite 180 Cleveland, OH 44122 |
| Contact | Lynn Hanigan |
| Correspondent | Lynn Hanigan MIM Software Inc. 25800 Science Park Drive – Suite 180 Cleveland, OH 44122 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-02-03 |