The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Her2 (4b5).
| Device ID | K121516 |
| 510k Number | K121516 |
| Device Name: | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika Ammirati |
| Correspondent | Erika Ammirati VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | NQN |
| Subsequent Product Code | NOT |
| Subsequent Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-22 |
| Decision Date | 2013-09-26 |
| Summary: | summary |