The following data is part of a premarket notification filed by Nucletronix, Inc. with the FDA for Stereotactic 60 Cobalt Gamma System--gammaknife.
| Device ID | K827583 |
| 510k Number | K827583 |
| Device Name: | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | NUCLETRONIX, INC. BLACKBURN CENTER Gloucestor, MA 01930 |
| Contact | Roy M Emanuelson |
| Correspondent | Roy M Emanuelson NUCLETRONIX, INC. BLACKBURN CENTER Gloucestor, MA 01930 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-30 |
| Decision Date | 1982-09-29 |