The following data is part of a premarket notification filed by Vision Rt Ltd with the FDA for Alignrt Plus.
| Device ID | K203387 |
| 510k Number | K203387 |
| 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 | 2020-11-18 |
| Decision Date | 2021-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056190500719 | K203387 | 000 |
| 05056190500252 | K203387 | 000 |
| 05056190500245 | K203387 | 000 |
| 05056190500238 | K203387 | 000 |
| 05056190500221 | K203387 | 000 |
| 05056190500207 | K203387 | 000 |
| 05056190500191 | K203387 | 000 |
| 05056190500184 | K203387 | 000 |
| 05056190500092 | K203387 | 000 |
| 05056190500078 | K203387 | 000 |
| 05056190500061 | K203387 | 000 |
| 05056190500054 | K203387 | 000 |
| 05056190500047 | K203387 | 000 |
| 05056190500269 | K203387 | 000 |
| 05056190500276 | K203387 | 000 |
| 05056190500443 | K203387 | 000 |
| 05056190500696 | K203387 | 000 |
| 05056190500665 | K203387 | 000 |
| 05056190500641 | K203387 | 000 |
| 05056190500627 | K203387 | 000 |
| 05056190500610 | K203387 | 000 |
| 05056190500566 | K203387 | 000 |
| 05056190500559 | K203387 | 000 |
| 05056190500542 | K203387 | 000 |
| 05056190500535 | K203387 | 000 |
| 05056190500528 | K203387 | 000 |
| 05056190500511 | K203387 | 000 |
| 05056190500481 | K203387 | 000 |
| 05056190500030 | K203387 | 000 |