The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gammaplan.
| Device ID | K103093 |
| 510k Number | K103093 |
| Device Name: | LEKSELL GAMMAPLAN |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Contact | Bo Nilsson |
| Correspondent | Bo Nilsson ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2010-12-21 |
| Summary: | summary |