The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Uronav (version 2.0).
| Device ID | K153073 |
| 510k Number | K153073 |
| Device Name: | UroNav (Version 2.0) |
| Classification | System, Image Processing, Radiological |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Contact | Kenneth Revennaugh |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-10-22 |
| Decision Date | 2015-11-16 |
| Summary: | summary |