The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Radiocameras Patient Positioning System.
| Device ID | K980750 |
| 510k Number | K980750 |
| Device Name: | RADIOCAMERAS PATIENT POSITIONING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Roger N White |
| Correspondent | Roger N White 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 | 1998-02-26 |
| Decision Date | 1998-05-20 |
| Summary: | summary |