The following data is part of a premarket notification filed by Vision Rt Ltd with the FDA for Alignrt Plus.
| Device ID | K212583 |
| 510k Number | K212583 |
| Device Name: | AlignRT Plus |
| Classification | Accelerator, Linear, Medical |
| Applicant | Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 2ju |
| Contact | Jade Dunphy |
| Correspondent | Jade Dunphy Vision RT Ltd Dove House, Arcadia Avenue London, GB N3 2ju |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056190500689 | K212583 | 000 |
| 05056190500672 | K212583 | 000 |
| 05056190500597 | K212583 | 000 |
| 05056190500580 | K212583 | 000 |
| 05056190500863 | K212583 | 000 |
| 05056190500214 | K212583 | 000 |