K121516 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC HER2 (4B5). This device is classified as a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II - Special Controls, product code NQN).
Submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 26, 2013, 492 days after receiving the submission on May 22, 2012.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860. Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention..
| 510(k) Number | K121516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2012 |
| Decision Date | September 26, 2013 |
| Days to Decision | 492 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |
| Definition | Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention. |