K130515 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC ER (SPI). 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 November 22, 2013, 268 days after receiving the submission on February 27, 2013.
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 | K130515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2013 |
| Decision Date | November 22, 2013 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Statement |
| 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. |