The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Contour Protegeai.
| Device ID | K193252 |
| 510k Number | K193252 |
| Device Name: | Contour ProtegeAI |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850009343093 | K193252 | 000 |
| 00850009343086 | K193252 | 000 |
| 00850009343079 | K193252 | 000 |
| 00850009343062 | K193252 | 000 |
| 00850009343055 | K193252 | 000 |