The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gamma Knife Target System, Model 24001.
| Device ID | K984328 |
| 510k Number | K984328 |
| Device Name: | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-03 |
| Decision Date | 1999-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340048306638 | K984328 | 000 |
| 07340048306607 | K984328 | 000 |