The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Lungpoint Virtual Bronchoscopic Navigation Vbn System.
| Device ID | K090095 |
| 510k Number | K090095 |
| Device Name: | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400 NORTH SHORELINE BLVD., SUITE 8 Mountain View, CA 94043 -1346 |
| Contact | Mahtab Fatemi |
| 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 | 2009-01-15 |
| Decision Date | 2009-03-13 |
| Summary: | summary |