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 |