The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthviz Advanced Planning Application With Stealthdti Package.
| Device ID | K081512 |
| 510k Number | K081512 |
| Device Name: | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDTRONIC NAVIGATION, INC. 3025 PERRY STREET Denver, CO 80212 |
| Contact | Kevin Morningstar |
| Correspondent | Kevin Morningstar MEDTRONIC NAVIGATION, INC. 3025 PERRY STREET Denver, CO 80212 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-30 |
| Decision Date | 2008-07-18 |
| Summary: | summary |