The following data is part of a premarket notification filed by Elekta Radiosurgery, Inc. with the FDA for Leksell Gamma Unit Model 23004,type B..
| Device ID | K924849 |
| 510k Number | K924849 |
| Device Name: | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ELEKTA RADIOSURGERY, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Contact | Thomas Parker |
| Correspondent | Thomas Parker ELEKTA RADIOSURGERY, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1995-11-20 |