The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Pr (1e2) Using Iscan Ht.
| Device ID | K142965 |
| 510k Number | K142965 |
| Device Name: | Virtuoso System For IHC PR (1E2) Using IScan HT |
| Classification | Automated Digital Image Manual Interpretation Microscope |
| Applicant | Ventana Medical Systems, Inc. 203 Ravendale Drive Mountain View, CA 94043 |
| Contact | Morteza Minaee |
| Correspondent | Yassine Labiad Ventana Medical Systems, Inc. 203 Ravendale Drive Mountain View, CA 94043 |
| Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-07-16 |