The following data is part of a premarket notification filed by Tripath Imaging, Inc. with the FDA for Ventana Image Analysis System - Her2/neu.
| Device ID | K051282 |
| 510k Number | K051282 |
| Device Name: | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | TRIPATH IMAGING, INC. 4025 STIRRUP CREEK DRIVE STE. 400 Durham, NC 27703 |
| Contact | Bryan J Tucker |
| Correspondent | Bryan J Tucker TRIPATH IMAGING, INC. 4025 STIRRUP CREEK DRIVE STE. 400 Durham, NC 27703 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2005-08-16 |