The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Lungpoint Planning And Virtual Bronchoscopic Navigation (vbn) Software.
| Device ID | K112051 |
| 510k Number | K112051 |
| Device Name: | LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE I Mountain View, CA 94043 |
| 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-07-18 |
| Decision Date | 2011-10-12 |
| Summary: | summary |