The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Radiocameras System Head/neck Application.
| Device ID | K994355 |
| 510k Number | K994355 |
| Device Name: | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION |
| Classification | Accelerator, Linear, Medical |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Angelique S Destruel |
| Correspondent | Angelique S Destruel 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 | 1999-12-23 |
| Decision Date | 2000-03-22 |
| Summary: | summary |