The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Immerge Image Correlation.
| Device ID | K991468 |
| 510k Number | K991468 |
| Device Name: | IMMERGE IMAGE CORRELATION |
| Classification | System, Image Processing, Radiological |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Roger White |
| Correspondent | Roger White SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-27 |
| Decision Date | 1999-07-06 |
| Summary: | summary |