The following data is part of a premarket notification filed by Vision Rt Limited with the FDA for Alignrt Plus.
| Device ID | K123371 |
| 510k Number | K123371 |
| Device Name: | ALIGNRT PLUS |
| Classification | Accelerator, Linear, Medical |
| Applicant | VISION RT LIMITED Dove House Arcadia Avenue London, GB N3 2ju |
| Contact | Norman Smith |
| Correspondent | Norman Smith VISION RT LIMITED 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 | 2012-11-01 |
| Decision Date | 2013-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B120ALIGNRT0 | K123371 | 000 |
| 05056190500016 | K123371 | 000 |
| 05056190500023 | K123371 | 000 |
| 05056190500085 | K123371 | 000 |
| 05056190500115 | K123371 | 000 |
| 05056190500122 | K123371 | 000 |
| 05056190500153 | K123371 | 000 |
| 05056190500306 | K123371 | 000 |
| 05056190500313 | K123371 | 000 |
| 05056190500436 | K123371 | 000 |
| 05056190500009 | K123371 | 000 |