The following data is part of a premarket notification filed by Tripath Imaging with the FDA for Ventana Image Analysis System - Pathway Her2 (4b5).
| Device ID | K061613 |
| 510k Number | K061613 |
| Device Name: | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | TRIPATH IMAGING 4025 STIRRUP CREEK DR. SUITE 400 Durham, NC 27703 |
| Contact | Bryan J Tucker |
| Correspondent | Bryan J Tucker TRIPATH IMAGING 4025 STIRRUP CREEK DR. SUITE 400 Durham, NC 27703 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-09 |
| Decision Date | 2007-01-10 |