The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Vantage Stereotactic System.
| Device ID | K190887 |
| 510k Number | K190887 |
| Device Name: | Leksell Vantage Stereotactic System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Contact | Helena Skar |
| Correspondent | Alf Laurell 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 | 2019-04-04 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340048311625 | K190887 | 000 |
| 07340201501634 | K190887 | 000 |
| 07340201501658 | K190887 | 000 |
| 07340201501719 | K190887 | 000 |
| 07340201501757 | K190887 | 000 |
| 07340201501825 | K190887 | 000 |
| 07340201502198 | K190887 | 000 |
| 07340201501764 | K190887 | 000 |
| 07340048311373 | K190887 | 000 |
| 07340048311458 | K190887 | 000 |
| 07340048311472 | K190887 | 000 |
| 07340048311601 | K190887 | 000 |
| 07340201501382 | K190887 | 000 |