The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Image Guidance Surgical System (ligs).
| Device ID | K961639 |
| 510k Number | K961639 |
| Device Name: | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 Stockholm, SE S-103-93 |
| Contact | Sverker Glans |
| Correspondent | Sverker Glans ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 Stockholm, SE S-103-93 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1996-07-26 |
| Summary: | summary |