The following data is part of a premarket notification filed by Vision Rt Ltd with the FDA for Alignrt Plus.
Device ID | K193431 |
510k Number | K193431 |
Device Name: | AlignRT Plus |
Classification | Accelerator, Linear, Medical |
Applicant | Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 2ju |
Contact | Arun Mahendran |
Correspondent | Arun Mahendran Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 2ju |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-10 |
Decision Date | 2020-01-03 |