The following data is part of a premarket notification filed by Vision Rt Ltd with the FDA for Alignrt Plus.
Device ID | K181218 |
510k Number | K181218 |
Device Name: | AlignRT Plus |
Classification | Accelerator, Linear, Medical |
Applicant | Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 2ju |
Contact | Chris Hannan |
Correspondent | Chris Hannan Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 Nju |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-07 |
Decision Date | 2018-08-07 |
Summary: | summary |