The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso (tm) System For Ihc Her2 (4b5).
| Device ID | K111543 |
| 510k Number | K111543 |
| Device Name: | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 919 HERMOSA COURT Sunnyvale, CA 94085 |
| Contact | Indu Lakshman |
| Correspondent | Indu Lakshman VENTANA MEDICAL SYSTEMS, INC. 919 HERMOSA COURT Sunnyvale, CA 94085 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-10-12 |
| Summary: | summary |