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 |