The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Collision Check.
| Device ID | K171350 |
| 510k Number | K171350 |
| Device Name: | Collision Check |
| Classification | Accelerator, Linear, Medical |
| Applicant | Radformation, Inc. 335 Madison Avenue 16th Floor New York, NY 10017 |
| Contact | Kurt Sysock |
| Correspondent | Kurt Sysock Radformation, Inc. 335 Madison Avenue 16th Floor New York, NY 10017 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-11-29 |
| Summary: | summary |