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 |