The following data is part of a premarket notification filed by Tripath Imaging, Inc. with the FDA for Ventana Image Analysis System.
| Device ID | K050012 |
| 510k Number | K050012 |
| Device Name: | VENTANA IMAGE ANALYSIS SYSTEM |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | TRIPATH IMAGING, INC. 780 PLANTATION DR. Burlington, NC 27215 |
| Contact | Bryan Tucker |
| Correspondent | Bryan Tucker TRIPATH IMAGING, INC. 780 PLANTATION DR. Burlington, NC 27215 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-05-06 |