The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Linac Scalpel Treatment Planning System.
| Device ID | K962792 |
| 510k Number | K962792 |
| Device Name: | LINAC SCALPEL TREATMENT PLANNING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Kurt R Smith |
| Correspondent | Kurt R Smith SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-17 |
| Decision Date | 1996-11-12 |
| Summary: | summary |