The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Autocontour Model Radac V2.
| Device ID | K220598 |
| 510k Number | K220598 |
| Device Name: | AutoContour Model RADAC V2 |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Radformation, Inc. 335 Madison Avenue, 4th Floor New York, NY 10017 |
| Contact | Kurt Sysock |
| Correspondent | Kurt Sysock Radformation, Inc. 335 Madison Avenue, 4th Floor New York, NY 10017 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-08-24 |