The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Vantage Stereotactic System.
| Device ID | K171123 |
| 510k Number | K171123 |
| Device Name: | Leksell Vantage Stereotactic System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Contact | Matilda Forsberg |
| Correspondent | Matilda Forsberg Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-09-15 |
| Summary: | summary |