The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gammaplan.
| Device ID | K151666 |
| 510k Number | K151666 |
| Device Name: | Leksell GammaPlan |
| Classification | System, Planning, Radiation Therapy Treatment |
| 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 | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-19 |
| Decision Date | 2015-09-03 |
| Summary: | summary |