Virtuoso System for IHC HER2 (4B5)
by Ventana Medical Systems, Inc.
510(k) K121516
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121516 | Date26 Sep 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NQN
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Virtuoso System for IHC HER2 (4B5) is an automated, operator-intervention microscope designed for immunohistochemistry (IHC) and image analysis. It is classified as a Class II medical device and supports computer-assisted scoring of HER2 protein expression in tissue samples, including both nuclear intensity and percent positivity assessment.
This system is intended for use in pathology laboratories to analyze formalin-fixed, paraffin-embedded tissue slides. It is supplied as a reusable device with FDA 510(k) clearance (K121516) under the Hematology advisory committee, and it operates under traditional review procedures. No specific sterility or MRI safety information is provided in the available data.
Other devices from Ventana Medical Systems
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Virtuoso System for IHC HER2 (4B5)?
The Virtuoso System is an automated microscope designed for immunohistochemistry and image analysis, specifically for assessing HER2 protein expression in tissue samples through nuclear intensity and percent positivity evaluation.
How is the Virtuoso System supplied and can it be reused?
The system is supplied as a reusable device designed for pathology laboratories to analyze formalin-fixed, paraffin-embedded tissue slides, with no single-use components mentioned in the available data.
What regulatory status does the Virtuoso System hold?
The Virtuoso System has FDA 510(k) clearance (K121516) under traditional review procedures and is classified as a Class II medical device, though no specific sterility or MRI safety information is provided.
What types of tissue samples can be analyzed with this system?
The system is designed to analyze formalin-fixed, paraffin-embedded tissue slides, providing computer-assisted scoring of HER2 protein expression in pathology laboratories.