The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gamma Knife Perfexion.
| Device ID | K151159 |
| 510k Number | K151159 |
| Device Name: | Leksell Gamma Knife Perfexion |
| Classification | System, Radiation Therapy, Radionuclide |
| 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 | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340048306539 | K151159 | 000 |