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 |